Quality

Sanofi US

QA OPS Manager B79 Viral PCU Lead

**Job Title: QA OPS Manager B79 Viral PCU Lead**

- Location: Swiftwater, PA

**About the Job:**

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as QA OPS Manager B79 Viral PCU Lead within our Quality Assurance team, will be to lead and drive quality over the B79 Viral Manufacturing, B78 Seed Facility and QC Facility.

This role provides leadership and direction for quality oversight of the vaccine drug product manufacturing. This leadership role collaborates with a group of highly skilled and technical colleagues toward an inspiring mission of creating high-quality life-saving vaccines. The QA OPS Manager -B79 Viral PCU Lead will lead a team of quality professionals overseeing the B79 Viral Manufacturing, B78 Seed Facility and QC Facility.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

**Main Responsibilities:**

- Ensuring that all site activities are conducted in compliance with applicable regulatory requirements and that valid manufacturing licenses and product permissions are maintained
- Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
- Overseeing the daily operations of the quality assurance team assigned, ensuring all activities align with company goals and regulatory requirements
- Ensuring the timely closure of quality events such as deviations, CAPAs, PQR, and change controls to maintain compliance and operational efficiency
- Overseeing all the investigations product-related (eg deviation, OOx) in their scope to ensure they are properly conducted, allowing appropriate risk assessment and product impact assessment
- Conducting regular audits of production processes to identify and address potential quality issues
- Collaborating with production to ensure quality standards are maintained throughout the product lifecycle
- Managing and resolving quality-related issues in a timely and effective manner
- Training and managing quality assurance operational team
- Monitoring and analyzing quality performance metrics, implementing corrective actions as needed
- Leading root cause analysis investigations for quality incidents and implementing preventive measures
- Participating in internal and external audits and regulatory inspections providing support and documentation
- Developing and implementing risk management strategies to mitigate potential quality issues
- Fostering a culture of quality and continuous improvement across the organization
- Overseeing the batch record review process for area within their scope, ensure compliance with regulatory requirements and company standards
- Reviewing and approving batch records and associated documentation
- Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)

**Following key decisions (D,A,I):**

- Establish and prioritize quality and compliance objectives for the site (D)
- Ensure the implementation and maintenance of robust quality systems, in line with global quality (D)
- Proactively implement remediation action from findings from internal and external audits related to quality issues (D)
- Advise on quality improvement initiatives and strategies (A)
- Escalate the issues when needed (I)
- Ensure the right level of training required for the team to perform routine tasks (D)
- Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)
- Advise on risk management strategies and plans (A)
- Advise on initiatives to promote a quality-focused culture (A)
- Approve documentation for batch disposition and update corresponding digital tool to allow release (D)

**Benefits of working in this role**:

- Be part of an inspiring mission to create life-saving vaccines
- Leading a skilled and motivated team of quality professionals
- The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus.

**About You:**

**Requirements and Qualifications:**

- Bachelors Degree in life sciences, engineering, or related technology degree - required.
- Minimum 5 years of experience in quality assurance within the pharmaceutical industry.
- Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
- Ability to analyze complex data and identify trends, issues, and solutions
- High level of accuracy and attention to detail in all quality assurance activities
- Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
- Proficiency in identifying problems and implementing effective corrective actions
- Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
- Fluent in English
- Knowledge of visual inspection principals and requirements preferred

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SP

\#LI-SP

\#LI-Onsite

\#Vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Pennsylvania

Aspen Neuroscience

Associate Director, Quality Assurance

The Associate Director, Quality Assurance strategic and operational leadership for the ongoing improvement of GxP quality systems and teams supporting late-stage clinical development, manufacturing, and commercial readiness. The role shapes and executes quality system strategy, establishes risk-based governance, and ensures that GMP, GCP, and GLP requirements are integrated across clinical and manufacturing operations. The Associate Director leads multiple QA functional areas, including document control, training, supplier quality, quality events, audit and inspection readiness, and batch disposition; advises senior leaders on significant quality and compliance matters; and develops teams and scalable systems that support organizational objectives. This is an on-site role in Torrey Pines, CA that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.

**DUTIES AND RESPONSIBILITIES:**

- Partner with senior Quality leadership to establish and execute the strategy, objectives, operating model, and multi-year roadmap for GxP quality systems supporting clinical development, manufacturing, and commercial readiness.
- Translate organizational priorities into functional plans, governance, resource requirements, budgets, schedules, and measurable outcomes for assigned QA areas.
- Shape departmental policies, standards, and risk-based quality practices, and influence organizational decisions that affect product quality, patient safety, data integrity, and regulatory compliance.
- Direct and continuously improve multiple QA functions, including document control, training systems, supplier quality, quality events (deviations, CAPA, change control, non-conformance), and batch disposition.
- Ensure compliant and timely execution of core QMS processes and provide QA direction on complex investigations, quality events, supplier issues, and disposition matters.
- Establish metrics, dashboards, and management-review processes to assess quality system health, identify systemic trends, and drive timely risk-based decisions and remediation.
- Lead enterprise inspection readiness and oversee internal, external, partner, and regulatory audits, including response strategy, commitments, and sustainable remediation.
- Anticipate, assess, communicate, and mitigate significant quality and compliance risks; develop practical contingency plans and escalate matters of organizational significance with clear recommendations.
- Serve as a senior Quality partner across functions and governance forums, aligning stakeholders and communicating performance, risks, resource needs, and strategic recommendations to senior leadership.
- Oversee external partners and suppliers, lead cross-functional quality initiatives, and develop QA talent through clear accountability, coaching, succession planning, and a culture of continuous improvement.

**EDUCATION AND EXPERIENCE:**

- Bachelor's degree in life sciences, health sciences, engineering, or a related field required; advanced degree preferred.
- Minimum 8 years of substantial experience in the cGMP pharmaceutical or biotechnology industry and progressive leadership of GxP quality systems in clinical and manufacturing environments.
- Late-stage clinical development, commercial manufacturing readiness, biologics, cell therapy, or stem cell manufacturing experience strongly preferred.
- Minimum 7 years of experience leading internal, external, supplier, or regulatory audits and inspection-readiness activities; Certified Quality Auditor (CQA) or equivalent certification preferred.
- Minimum 7 years of progressive people leadership experience, including responsibility for developing teams, managing performance, allocating resources, and leading through organizational change.
- Experience with electronic quality management systems and electronic batch record systems preferred.

**JOB SPECIFICATIONS:**

- **Quality Systems Leadership:** Advanced capability to design, optimize, and scale GxP quality systems for late-stage development, manufacturing, and commercial readiness to ensure compliance, efficiency, and long-term sustainability
- **Regulatory Expertise:** Advanced knowledge of GMP, GCP, GLP, and global regulatory frameworks including FDA, EMA, and ICH expectations, with the judgment to apply requirements to complex quality and operational decisions.
- **Quality Strategy and Governance:** Ability to translate company and functional objectives into an integrated quality strategy, governance model, priorities, policies, and measurable outcomes.
- **Risk Assessment:** Ability to evaluate ambiguous, high-impact issues, understand cross-functional interdependencies, and make timely, risk-based decisions that protect patients, product quality, compliance, and business continuity.
- **Executive Influence:** Ability to communicate with and influence senior and executive leaders on matters of organizational significance, including competing priorities, resource decisions, compliance risk, and remediation strategy.
- **Cross-Functional Leadership:** Ability to create alignment across functions, programs, partners, and external stakeholders and lead complex initiatives without relying solely on formal authority.
- **Business Acumen:** Strong understanding of the product development lifecycle, manufacturing operations, company priorities, and the biotechnology landscape to inform quality strategy and resource allocation.
- **People Leadership:** Proven ability to lead multiple workstreams or quality disciplines, develop leaders and technical talent, establish accountability, and build a high-performing quality culture.
- **Inspection Readiness:** Deep understanding of global audit and inspection expectations, with the ability to establish and sustain an organization-wide state of readiness and lead effective responses and remediation.
- **Operational Excellence:** Ability to establish plans, budgets, staffing models, schedules, performance measures, and external support strategies that meet corporate requirements.
- **Communication:** Exceptional written, verbal, and presentation skills with the ability to distill complex quality, technical, and regulatory matters into clear recommendations for diverse audiences.
- **Analytical Thinking:** Ability to synthesize metrics, trends, inspection intelligence, and operational data to identify systemic risk, evaluate effectiveness, and guide strategic decisions.
- **Travel:** Ability and willingness to travel nationally to support GxP audits, inspections, partner oversight, and quality activities.

**WORKING CONDITIONS**

General Office Environment. This is an indoor position that requires sitting at a desk for extended periods of time and the ability to type and use a computer. The noise level in the work environment is usually quiet to moderate.

Some Cleanroom access is required

**PHYSICAL DEMANDS**

While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 15 pounds.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job.

**EEO and Employment Eligibility:**

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees. Aspen is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future.

**Total Rewards and Culture:**

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.

The anticipated salary range for candidates who will work in San Diego is $187,099 - $228,676 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.

California

SBM Management Services

Quality & Compliance Manager

SBM Management is seeking a hands-on Quality & Compliance Manager to support the execution, compliance, and continuous improvement of Critical Environments services across regulated life sciences client sites.

This field-based role will work closely with site operations, frontline cleaning teams, and client Quality representatives to assess program effectiveness, ensure adherence to GMP requirements, strengthen quality systems, and drive sustainable improvements.

The ideal candidate brings practical experience in pharmaceutical, biotechnology, or other GxP regulated operations, along with the ability to translate quality requirements into effective daily practices.

Compensation: $110,000-$120,000 per year

Travel up to 50% required

**Roles & Responsibilities**

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.

- Perform on-site assessments determining effectiveness of program in meeting contractual SOW and quality of service delivery
- Make recommendations, share best practices and implement actions to improve program SOW and/or quality service delivery
- Investigate customer complaints regarding quality and support RCA activities
- Identify at risk programs and facilitate CAPA process and required follow up actions where needed
- Monitor internal processes for quality standards via on-site and remote program formal assessments
- Support new account transitions as assigned
- Guide and assist prior to and during high level client service inspections (i.e. Regulatory, Partner, VIP)
- Conduct personnel compliance audits, develop and/or verify work schedules to ensure adequate service
- Perform classroom style and on-the-job trainings (MGMT & Staff) to address and correct areas of concern
- Complete routine reporting and deliverables associated with the position keeping Dept. and local management team informed of significant issues identified during activities and actions taken to improve
- Support operations feed forward loop through proper execution of the CE Quality Events as assigned
- Audit inventory supplies and equipment for condition and SOW delivery effectiveness
- Develop new approaches to solve problems identified during quality activities
- Investigate and promote improved equipment and methods
- Implement organization policies and goals
- Facilitate budget requests, identify areas enhancements are necessary or reductions can be made
- Assist with plans, budgets, and schedule modifications including cost estimates, bid sheets and contracts
- Participate in the development of long-range plans for program/process improvements
- Support assigned sites in driving organic growth and new client opportunities
- Collect benchmarking data for preparing estimates, labor hours, expenses, and other metrics
- Maintain a safe work environment for self and employees
- Ensure compliance with local, state, and federal regulations, such as, FLSA, OSHA, ADA, etc.
- Direct supervisory management engaged in support of controlled environment programs
- Act as liaison between company, customers, clients, employees, and subcontractors
- Assist with human resource concerns and issues
- Some travel is required for this position

**Qualification**  
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

**Education and/ or Experience**  
A.A. Degree required with 2+ years of experience, or equivalent combination of education and experience

**Certificates, Licenses, Registrations**  
CPR/AED/First Aid certification a plus  
A valid driver's license may be required for this position based on business needs. Employees required to drive as part of their job duties must maintain an acceptable Motor Vehicle Record (MVR) and meet company driving eligibility requirements.

Completed all safety and task training certification

May be required to be forklift certified

**Knowledge, Skills, and Abilities**  
Bilingual a plus  
Ability to read and interpret instructions, procedures, manuals, and other documents Strong verbal and written communication skills  
Knowledge of cleaning methods and equipment and willing to share with team Knowledge of the upkeep and care of the cleaning equipment  
Knowledge of cleaning compounds and chemicals, and their safe, efficient use  
Customer service, problem solving, time management, project management, planning, excellent communication, presentation, interviewing, coaching, and training skills  
Knowledge of Microsoft Office and Computer Skills  
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community  
Ability to effectively present information and respond to questions from groups of managers, customers, employees, and general public

**Supervisory Responsibilities**

Carries out management responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, planning, assigning, and directing work; performance evaluations; rewarding and disciplining employees; addressing complaints and resolving problems. Ensure employees are properly trained on tasks and safety requirements.

**Physical Demands & Work Environment**

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit and talk or listen. The employee must be able to lift and/or move up to 35 pounds.  
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

AbbVie

(Senior) Software Validation Engineer - Quality Assurance (all genders) (fulltime, regular)

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Welcome to AbbVie! As part of an international company with ca. 57,000 employees worldwide and around 3,500 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

Together, we break through – as (**Senior) Software Validation Engineer Quality Assurance (all genders)**

The (Senior) Software Validation Engineer - Quality Assurance (QA) provides quality oversight and subject matter expertise for GxP computerized systems across GMP, GLP, GCP, and PV-regulated areas within the R&D organization. The role is responsible for interpreting regulatory and quality requirements, guiding risk-based software validation and Computer Software Assurance (CSA) activities, supporting data integrity compliance, and ensuring inspection readiness through effective validation lifecycle management, governance, training, and business partner support.

**Make your mark:**

- Provide interpretation, guidance, and training for business partners regarding software qualifications / validation and related regulatory regulations / guidelines, including data integrity and AbbVie policies / procedures.
- Support Business System Owner and Business SME with their IT software projects and goals.
- Advise project teams, Business System Owners, and Business SMEs on risk-based CSV / CSA strategy, validation planning, testing approach, traceability, and documentation expectations for new systems and system changes.
- Review / approve various software qualification / validation documentation, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.
- Provide technical guidance, coaching, and training to RDQA colleagues and business partners on CSV / CSA, data integrity, validation, and quality system expectations.
- Defend software qualification / validation during regulatory authority inspections and third-party audits.
- Support business in understanding the process of inspection/ audit responses.
- Recommend a plan of action for satisfactory resolution of quality and regulatory compliance issues.
- Participate in CAPA activities, provide support to event owners and Business System Owners, review and approve related records.
- Provide guidance, direction, and support to R&D QA staff.
- Participate in process improvement projects and assist with the development of compliance plans and strategies.

Qualifications

**This is how you make a difference:**

**Required Qualification**

- Graduated Engineer (FH) or bachelor's degree in natural sciences, several years of experience in drug product development or production or validation / qualification in the pharmaceutical field.
- Minimum of 5 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification / validation, documentation, or compliance.
- Key leadership competencies to include relationship-building, ability to influence, knowledge of the business, sound judgment, conflict resolution, excellent interpersonal skills.
- Ability to provide innovative ideas to improve quality and compliance that create value, always seeking new information and insights (internal and external).
- Excellent communication capabilities and teamwork capacities, on a local and global level.
- Excellent knowledge of the English and the German language (spoken and written).

**Preferred Qualification**

- Experience with development, oversight, validation, or governance of AI/ML-enabled technologies, advanced analytics platforms, automation solutions, or digital quality systems, including application of risk-based assurance and data integrity principles.
- Knowledge of emerging industry guidance related to AI/ML, computerized systems quality, and digital health technologies.

**What we offer you:**

- with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work-life balance
- with a corporate health management that offers comprehensive health and exercise programs
- with company social benefits
- with a wide range of career opportunities in an international organization
- with top-tier, attractive development opportunities
- with a strong international network

At multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Any questions? Feel free to email us at TalentAcquisition.de@abbvie.com – We are looking forward to hearing from you!

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Other Non-US

Quality Manager II, Combination Products & Medical (all genders) (fulltime, regular)

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

Welcome to AbbVie! As part of an international company with ca. 57,000 employees worldwide and around 3,500 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

Together, we break through – as **Quality Manager II, Combination Products & Medical (all genders)**

The Quality Manager II Combination Products & Medical is responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations.

**Make your mark:**

- Assure proper integration and support of device, drug and biologics regulations.
- Lead product team members through the design process providing guidance while working closely with research organizations to ensure potential product issues are identified and addressed to ensure robust product requirements.
- Ensure design control documentation as well as design change control requirements are met by assessing the impact of a change on the safety, efficacy of the combination product/device.
- Perform 3rd party supplier management while reviewing and approving supplier design control activities, assess supplier changes, provide input to quality agreements, and maintain appropriate balance between internal oversight actions and supplier controls.
- Partner with third party vendors, manufacturers and laboratories to ensure that combination products/devices follow internal and regulatory agency standards, including supplier site visits and support of supplier audits.
- Foster close global collaboration with R&D, Operations and Commercial Operation functions to identify and mitigate product risks while performing risk assessment of changes on safety and efficacy, utilizing risk control tools such as FMEA.
- Identify gaps in existing processes as well as the need for new processes in the cross-functional collaboration.
- Guide project development in global and local product development teams to proactively address quality-related issues, advise internal business partners and cross-functional groups on QA expertise as well as medical device/combination product regulations.

Qualifications

**This is how yo make a difference:**

- Bachelor’s degree in biomedical engineering, mechanical engineering, or another relevant technical or scientific discipline.
- Minimum 6+ years of industry experience in Quality Assurance, development or healthcare related field. Medical device experience required. Combination Product and 3rd party supplier management experience preferred. Less experience considered with advanced degree.
- Understanding of regulations and standards affecting combination products and medical devices required. Must have negotiation skills and have been seen to take a position on Quality issues and standards and must be capable of clearly and logically justifying such positions.
- Sound technical understanding of product development (e.g. approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control.
- Well-versed in risk management methodologies and their application.
- Able to take the initiative to identify and implement new approaches to resolve problems, able to challenge scientific arguments - strong analytical approach to identify problem areas and effective solutions.
- Work independently and in a global team environment, and with all levels of personnel within the organization.
- Excellent knowledge of the English and the German language (spoken and written).

**What we offer you:**

- with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work-life balance
- with a corporate health management that offers comprehensive health and exercise programs
- with company social benefits
- with a wide range of career opportunities in an international organization
- with top-tier, attractive development opportunities
- with a strong international network

At multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Any questions? Feel free to email us at TalentAcquisition.de@abbvie.com – We are looking forward to hearing from you!

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Novo Nordisk

Maintenance Engineer I

**About the Department**

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including **14 paid holidays**
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Support proper implementation & execution of maintenance activities for API production equipment & systems within DAPI-US facility. Improve the reliability & performance of API operations tracks with respect to equipment/systems maintenance. Utilize a reliability centered mindset to maximize plant productivity, while maintaining equipment performance & longevity. Primary tasks include: Lead & coordinate maintenance performance improvement projects & initiatives. Support manufacturing & production support teams to ensure maintenance compliance. Provide technical support to the site & stakeholders to meet business goals. Coach & mentor members of the maintenance team.

**Relationships**

Reports to Senior Manager, Maintenance Support.

**Essential Functions**

- Write/review maintenance plans, specifications & SOPs
- Participate in equipment/system design reviews & support equipment installation, commissioning & qualifications
- Assist in maintaining quality & schedule within area of responsibility
- Establish & maintain positive working relationship with internal & external engineering & operations stakeholders
- Lead & provide technical support for investigation, troubleshooting & problem resolution of equipment & system operational issues
- Support development, implementation & improvement of equipment & systems maintenance plans during operation
- Continuous improvement: verify process equipment & satisfy design requirements/expectations
- Knowledge sharing with local & DK facilities
- Develop knowledge of risk assessment documents, such as requirements risk assessments (RRA's)
- Support the review & updating of engineering & specification documentation (process flow diagrams, P&IDs, user specifications, etc.)
- Drive maintenance team adherence to PSM requirements & best practices
- Participate in the review & updating of process & system risk assessments
- Other accountabilities, as assigned.

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. May require corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. Occasionally performs critical job functions in extremely cold work environments. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Ability to work in loud noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid drivers license.

**Qualifications**

- Bachelor's Degree in engineering (preferred degree in maintenance, mechanical, chemical, electrical, bio-process engineering), or equivalent industrial, military, or vocational training combined with experience required
- Minimum three (3) years of experience working directly in utilities or process equipment maintenance, or other directly related field required
- Demonstrated experience in plant operations & maintenance with proven knowledge in RCA, troubleshooting, problem resolution & continuous improvement preferred
- Experience working in a pharmaceutical manufacturing environment with cGMPs requirements or other regulated industry or manufacturing environment a plus
- Six Sigma Green Belt certification or cLEAN® 2-star desired a plus
- Demonstrated experience in maintenance processes & mechanical systems preferred
- Practical knowledge in the following areas: mechanical systems operations, root cause analysis (RCA), reliability centered maintenance (RCM), process hazard assessment (PHA), process safety management (PSM) & process improvement methodologies (Six Sigma, Lean Sigma) a plus
- Technical/process/functional knowledge of utility systems components maintenance & operation including cooling & chilled water, plant steam (HP & LP), compressed air, clean steam & purified water preferred
- Technical/process/functional knowledge of specific equipment maintenance & operation including but not limited to pumps (centrifugal, PD, diaphragm, mag drive, other), heat exchangers, control valves, mixers, agitators & filtration preferred
- Technical/process/functional knowledge of API systems components maintenance & operation to include centrifugation, spray drying & chromatography a plus
- Experience with using records control systems (SAP, CMMS or similar system) a plus
- Ability to read & understand equipment schematics, P&IDs, PFDs, wiring diagrams, CAD drawings & other specialized documentation required
- Knowledge & understanding of technical documents such as URS, SAT, FAT, qualification & validation protocols a plus
- Experience using controls & control interfaces for PLC, PCS, BMS & DCS systems a plus
- Ability to independently apply engineering techniques & analysis within the discipline preferred
- Strong project management skills a plus
- Excellent oral & written communication skills preferred
- Proven expertise in developing/planning/coordinating maintenance activities & following up on results preferred
- Experienced in creating &/or revising work plans for complex problems being resolved by cross functional teams a plus

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

North Carolina

Internship- Maintenance Engineering

**About the Department**

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. As a result, our employees embark on life-changing careers with opportunities for mobility and growth within a global organization. At Novo Nordisk, you will work with the best manufacturing professionals in the industry.

Our new Active Pharmaceutical Ingredients (API) facility houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. Are you ready to help make what matters? Then, we are ready for you!

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**NNPILP Early Talent Summer Internship Program**

At Novo Nordisk, interns will have the opportunity to work closely with experienced industry professionals and gain valuable, hands-on, full-time work experience. For ten weeks, interns will be immersed in the environment of a global pharmaceutical company and contribute to the line of business by providing sustainable and meaningful project work. Our internship program also includes instructor-led trainings, a leadership engagement series, as well as insightful lunch and learns.

Program Start: May 17, 2027

Program End: July 23, 2027

**Scope of Position**

Intern will help support the maintenance engineering activities by collecting and analyzing data both in Fermentation and Recovery departments.

Interns will also attend all department and group meetings. Intern will work at the direction of the assigned supervisor.

**Physical Requirements**

- 0% overnight travel required.

**Qualifications**

- Pursuing an undergraduate or graduate degree.
- Mechanical Engineer majors preferred.
- Must be a rising junior or rising senior with a 3.0 GPA or above.
- Excellent computer skills to include Proficiency in Excel, Word & familiarity/capability in most other Microsoft Office applications.

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Specialist - Rebate Operations and Assurance

**About the Department**

The Finance & Operations department brings insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance & Operations works closely across the organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our focus on innovation ensures we're constantly building future capabilities. We're responsible for regulating accounting, upholding workplace safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will have the opportunity to build a career in a global business environment. We encourage our employees to make the most of their talent, and we reward hard work and dedication with opportunities for continuous learning and personal development. Are you ready to maximize your potential with us?

**The Position**

This position supports rebate processing and business assurance activities under Rebate Operations & Insights. Ensures timely and accurate payment of rebate payments for Strategic and Non-Strategic customers for Commercial, Part D and Coverage Gap. Reviews and analyses the results of rebate calculations and identifies and reports status and exceptions. Provides analytical and consulting services in support of delivering and executing projects related to Business Assurance.

**Relationships**

The position reports to the head of Rebate Operations and works closely with Business Assurance, Strategic Pricing & Contracting and other field and home office stakeholders. External relationships include Managed Care & Medicare customers, Market Access and System Vendors.

**Essential Functions**

- Assists customers and management with questions or problems arising with contracts and payments and troubleshoots accordingly
- Assists with both internal and external audits
- Creates special reports and provides analysis support to management based on trends and needs
- Ensures accurate reporting to finance and treasury (i.e., monthly treasury reporting, monthly and periodic reconciliations to other reporting systems)
- Identifies and analyses performance trends and provides recommendations and insights to management
- Identifies missing claims data and works with customers in gathering and obtaining this data
- Inputs, reviews, validates, processes and analyses rebate payments and adjustments ranging from $100K - $200M or more; ensures payments are paid within the required timeframes and conditions, as stated in the contractual agreements
- Prepares and provides contract reports (i.e., sales, rebate pricing, reconciliation) to field sales and home office management
- Responsible for proper distribution of funds and reporting to field sales and rebate customers
- Reviews and analyses contract terms and conditions of contracts. Ensures data in validation and rebate systems reflect the contract terms for accurate processing
- Reviews and recommends contract language to management
- Formats incoming claims data (received on tape, diskette, etc.) from contract customers; manipulates data to ensure proper format
- Provides support for data loading efforts to ensure that all data received is loaded accurately and in a timely manner prior to data validation. Coordinates with external source for loading and scrubbing of rebate claims data
- Works with external vendor and customer to resolve data issues
- Provides support for ensuring all data is received and accurately tracked to ensure on time payment
- Provides support for ensuring all documentation for payments and contracts are filed and updated accurately
- Provides support for generating and distributing all supporting reports provided to the field and customers for reconciliation
- Assists with implementing enhancements for data validation and rebate systems
- Creates and maintains rebate agreements in the rebate system
- Ensures that A/P vendor information is updated accurately and that payments are issued as expected
- Ensures that all activities meet internal and/or external service level agreements and Sarbox controls
- Maintains membership and formulary linkages in rebate system
- Ad hoc Business Assurance reporting activities and active participation in adhoc projects to ensure compliance across rebate operations

**Physical Requirements**

0-10% overnight travel required.

**Qualifications**

- A Bachelor 's degree or equivalent experience required
- Advanced PC skills required
- Contracting and Pricing Knowledge and Expertise Required - Understands contracting concepts and processes and the impact of pricing activities on contracting. Applies knowledge of changes in laws and competitive landscape to make sound business decisions
- Data manipulation skills through a third-party vendor for data scrubbing
- Experience in using financial and/or statistical tools to analyse contract data required
- Microsoft Access and Advanced skills in Excel required
- SQL experience preferred
- Requires a minimum of 4 years relevant experience
- Strong analytical, quantitative and qualitative analysis skills required
- Strong skills with Model N
- Self-motivator who seeks to improve accuracy and efficiency of analytical work and business processes. Strong attention to detail required
- Planner and forecaster savvy with recognizing trends, establishing forward progress and focusing on the big picture as well as the small details

The base compensation range for this position is $83,400 to $150,200. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

New Jersey

Eli Lilly and Company

Sr. Scientist - Sterility Assurance - Advanced Therapies Manufacturing

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly recently opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

**Job Description**

The Sr. Scientist - Sterility Assurance – Technical Services/Manufacturing Scientist (TS/MS) role is a technical position that develops and implements the site’s sterility assurance related initiatives and provides technical leadership with regard to sterility assurance & environmental monitoring strategies. Primary objectives include the start-up and compliant manufacturing of gene therapy drug product and drug substance, particularly as it relates to development and implementation of sterility assurance strategies, including environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, and sterility assurance risk management.

**Key Objectives/Deliverables**

- Understand the scientific principles required for manufacturing gene therapy drug products, including the interaction of the chemistry, equipment, aseptic processes, sanitization, and sterilization.
- Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
- Provide technical support on cleaning deviations/events and assist in root cause analysis.
- Provide technical support for all start-up activities related to sterility assurance programs (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
- Ensure site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level
- Provide technical guidance to the Process Team for sterility assurance programs
- Lead or provide technical support for root cause investigations related to sterility assurance programs
- Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements
- Perform periodic review of environmental monitoring data
- Lead or support risk assessments related to sterility assurance programs
- Create, execute, review, and/or approve technical documents related to sterility assurance programs
- Create, execute, and/or evaluate change controls related to sterility assurance programs
- Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends
- Participate in continuous improvement projects to improve quality performance at the site
- Participate or provide guidance for sterility assurance programs during internal and external audits, including regulatory inspections, as needed
- Serve as cleaning/sterility assurance interface external to the LP2 site
- Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives
- Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities

**Basic Requirements:**

- Bachelors in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
- 2+ years of experience supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance validation, microbiology laboratory, TS/MS, quality assurance, etc.)
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide sponsorship for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1 visa categories.

**Additional Preferences:**

- In depth knowledge of gene therapy drug product manufacturing
- Strong interpersonal and teamwork skills
- Strong self-management and organizational skills
- Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
- Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations
- Demonstrated successful leadership of cross-functional teams
- Experience with data trending and analysis
- Ability to analyze complex data and solve problems

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$67,500 - $173,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Maintenance Technician III (M-F 6:30 AM-3 PM)

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

M-F 6:30 AM-3 PM

**Company Description**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<https://nam12.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.abbvie.com%2F&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ouW0EWAXMc6feS9YMhOrX50Xcr7u7esYey2hTi3aXEs%3D&reserved=0>). Follow @abbvie on [X](<https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftwitter.com%2Fabbvie&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=NB%2BpWyw5752pXI4BpdVAdYgTngw%2FY%2B2lxdjzuU62mik%3D&reserved=0>), [Facebook](<https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.facebook.com%2FAbbVieGlobal%2F&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=pxrMl8T5PQl8HU8Xhph7jSamZXR%2Fqlh%2FTMIodipTPfs%3D&reserved=0>), [Instagram](<https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.instagram.com%2Fabbvie%2F&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=NwEPo8j8wQP42UyWxJuNXoHtRJW9IQ8qnjxx6705e8k%3D&reserved=0>), [YouTube](<https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.youtube.com%2Fuser%2FAbbVie&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=%2Fz0FnNhXfkO2DHSZdZ2mGo6WQ1oEyKQTGDujo0hZDoQ%3D&reserved=0>), [LinkedIn](<https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=eBnFZu5pxx5eG%2F%2BGHQXtjVOLh5olOf3QvjuzpAfYi0E%3D&reserved=0>) and [Tik Tok](<https://www.tiktok.com/@abbvie>).

**Job Description**

Independently perform Senior level technical support within the maintenance department. Trains lower-level Technicians on more advanced tasks.

Responsibilities

- Adhere to Abbvie’s code of conduct; Maintains the function of department assets to ensure reliable equipment and quality standards are met.
- Assists in root cause investigation and reliability centered maintenance analysis Capable of training others on tasks.
- Is proficient in multiple skilled trade disciplines and creates or edits maintenance job plans
- Intermediate computer skills (MS Windows).
- Fully proficient in their core function, performing advanced level tasks
- Assist cross functional teams outside of the maintenance organization
- Supports continuous improvement projects and safety initiatives within the maintenance organization and/or the site
- Understands and follows all safety and GMP regulations
- Assist cross functional teams outside of the maintenance organization

\#LI-AL1

Qualifications

- HS diploma with 10+ yrs. Experience or Relevant Certificate with 5+ yrs. experience or Associates technical degree with 3+ yrs. Experience, or proficient in two or more skilled maintenance functions.
  CMRT (Certified Maintenance and Reliability Technician) or equivalent accreditation desired
- Knowledge and ability to use advanced tools (i.e. machine tools, diagnostic tools, predictive tools)
  Intermediate computer skills (MS Windows). Electrical experience up to 480V is a plus.
- Relevant experience is pharmaceutical packaging or GMP environment is preferred.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Illinois

Amgen

Product Quality Director - Hybrid Modalities

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Product Quality Director - Hybrid Modalities**

**What you will do**

Lets do this. Lets change the world. In this vital role you will be the champion for a product team as the Product Quality Leader (referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization. The PQL has responsibility for working with PQ staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional areas on the resolution of issues associated with process/manufacturing, in process controls, analytical methods, specifications, comparability, stability, reference standards, importation testing, investigations, change control, regulatory submissions and inspections. The PQL has responsibility for inspiring change to implement operationally efficient processes and corporate alignment across international sites. As a leader in Product Quality, the successful candidate is expected to have experience, knowledge and understanding of large and small molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Amgen Quality Management Systems.

Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies were employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.

This role is directly responsible for the product quality and related activities (e.g., comparability, specifications, stability, annual product review) in support of the Product Development Team (PDT). The PQL provides scientific oversight for the product quality of pivotal and/or commercial product(s) including timely product data review, ownership of GMP documents and regulatory filing sections, execution of transactions in relevant GMP system, and support for regulatory audits and responses to questions. The individual is directly responsible for leading a Product Quality Team (PQT), including oversight of the product stability programs, providing indirect staff management and guidance to members of the PQT.

**Key Responsibilities include:**

- Provide effective, cross-functional quality leadership, and manage multiple, complex long-term PDT deliverables for hybrid modality programs (such as ADCs), including actions required for the PQT/APR; specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and PQ owned regulatory filing sections and RTQs
- Provide expertise in science and risk-based evaluation of complex processes and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues
- Demonstrate proficiency in oral and written communication of complex information to Amgen leadership, peers and regulatory agencies including communications associated with inspectional activities
- Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
- Understand and respond to the impact of emerging scientific/technical trends and their implications for Amgen
- Actively mentor new and existing team members to develop Product Quality core skills

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a self-starter with these qualifications.

**Basic Qualifications:**

- Doctorate Degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience OR
- Master's Degree & 7 years of Quality, Operations, Scientific, or Manufacturing experience OR
- Bachelor's Degree & 9 years of Quality, Operations, Scientific, or Manufacturing experience

**Preferred Qualifications:**

- Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field
- Expertise in the areas of large and small molecule and bioconjugate development, analytical testing, and industry regulations
- 8+ years of pharmaceutical experience with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience
- 6+ years working in a regulated environment (direct GMP)
- 4 years experience managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
- 2+ years experience as a technical expert or product champion
- 1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation.
- 1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
- Experience in Project Management in support of product development
- Knowledge of protein and small molecule quality, compliance and regulatory requirements
- Knowledge of analytical techniques used for small molecule and protein product quality control
- Understanding of drug substance and drug product development and manufacturing
- Strong leadership and management skills
- General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals
- Previous experience working on a cross-functional team in a matrix environment
- Excellent written and verbal communication skills, including facilitation and presentation skills

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Principal Product Quality Leader (Synthetics)

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Principal Product Quality Leader (Synthetics)**

**What you will do**

Lets do this. Lets change the world. In this vital role you will provide technical expertise and product leadership to the Product Quality organization. As a product expert in Quality, the Principal Product Quality Leader has responsibility for working with Product Quality Leaders, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on projects, issue resolution, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.

Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies were employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.

This role will support one or more of Amgen's synthetic products. The individual will provide technical expertise and project support to the relevant Product Quality Team(s) to develop, implement, and manage strategy for Quality to meet the Product Development Team goals. The individual will be directly responsible for Product Quality related tasks including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (change control, data systems, etc), and product data management, including comparability assessments, annual product reviews, and product quality risk assessments. In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health. This role is preferred to be on site at one our Amgen locations, remote will be considered if applicable.

**Key Responsibilities include:**

- Provide effective, cross-functional quality leadership, and support PDT deliverables for late phase and commercial synthetic programs, including actions required for the PQT, APR, specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and PQ owned regulatory filing sections and RTQs
- Support science and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues
- Demonstrate proficiency in oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
- Demonstrate proficiency in knowledge of cGMP and international regulatory expectations

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.

**Basic Qualifications:**

- Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience OR
- Masters degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience OR
- Bachelors degree & 6 years of Quality, Operations, Scientific, or Manufacturing experience OR
- Associate's degree and 10 years of Quality, Operations, Scientific or Manufacturing experience OR
- High School Diploma/GED and 12 years of Quality, Operations, Scientific or Manufacturing experience

**Preferred Qualifications:**

- B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
- 6+ years working in a regulated environment (either direct GMP or technical support)
- 1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation
- 1+ year experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
- Experience in Project Management in support of pharmaceutical development
- Understanding of synthetic pharmaceutical bulk and drug product development, manufacturing, and analytical techniques
- General knowledge of cGMP and US & international filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals
- Experience working on a cross-functional team in a matrix environment
- Excellent written and verbal communication skills, including facilitation and presentation skills
- A strong foundation in chemistry and experience with new synthetic modalities/ technologies such as peptides, siRNA, new extended release formulations, and or combination products is a plus

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

R&D Supplier Quality Manager

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**R&D Supplier Quality Manager**

**What you will do**

Lets do this. Lets change the world. Amgen is seeking a highly motivated R&D Supplier Quality Manager to support the qualifications, oversight, and continuous improvement of suppliers that contribute to Amgens R&D pipeline and our mission to serve patients.

In this role you will support the operational execution of supplier quality management processes for R&D suppliers under GCP, GLP, and GPvP regulations, including suppliers that provide, host, develop, validate, maintain, or support GxP computerized systems used to support regulated preclinical and clinical activities. Working cross-functionally with stakeholders across Quality, Procurement, R&D, Information Systems, Cybersecurity, Privacy, and business process owners, you will provide hands-on oversight of third-party suppliers to ensure compliance, data integrity, patient safety, risk mitigation, and continuous improvement across the supplier lifecycle.

**Key Responsibilities**

- Conduct risk-based supplier assessments, qualification, audit and lifecycle management, including quality agreements across various R&D service categories.
- Lead or support risk-based qualification and ongoing oversight of suppliers that utilize and/or provide GxP computerized systems, interfaces and devices to support clinical and preclinical activities.
- Assessment and oversight of supplier AI-Enabled GXP computerized systems used to support clinical and preclinical activities ensuring compliance to defined procedural controls, policies and standards .
- Plan, lead, and document risk-based audits of supplier GxP computerized systems and associated quality processes to assess regulatory compliance, validation and lifecycle controls, data integrity, security, and the effectiveness of corrective and preventive actions.
- Assess supplier quality systems and controls for computerized system lifecycle management, including validation, data integrity, security, access management, change and configuration management, incident and problem management, backup, recovery, business continuity, and decommissioning.
- Review risk-appropriate quality and technical requirements in supplier contracts and quality agreements, including validation documentation, audit trails, electronic records and signatures, subcontractor controls, regulatory inspection support, data ownership, data retention, and notification of significant changes or incidents.
- Participate in supplier governance and periodic reviews; evaluate service performance, validation status, changes, deviations, incidents, audit outcomes, emerging risks, and CAPA effectiveness, and escalate material GxP or data integrity concerns.
- Support inspection readiness and regulatory responses related to suppliers computerized systems; partner with system owners and subject-matter experts on supplier risk acceptance, remediation, continuity, transition, and exit decisions.
- Monitor supplier performance, track KPIs, and escalate quality issues when appropriate.
- Coordinate and/or execute supplier audits, manage findings, initiate quality records, and ensure timely CAPA closure.
- Maintain supplier data in quality systems (e.g., Veeva, TrackWise) to ensure accuracy and inspection readiness.
- Engage with suppliers to align requirements, governance and process improvement initiatives.
- Ensure compliance with procedures, perform quality checks, and contribute to continuous improvement.
- Collaborate with internal teams (R&D, Supply Chain, Sourcing, QA) to assist in the development and execution of supplier quality strategies.

**Travel**

- Up to 10% domestic and international travel may be required for supplier engagements and audits.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborative partner with these qualifications

**Basic Qualifications:**

- Doctorate degree OR
- Masters degree and 2 years of Science, Engineering, or experience in a related field OR
- Bachelors degree and 4 years of Science, Engineering, or experience in a related field OR
- Associates degree and 8 years of Science, Engineering, or experience in a related field OR
- High school diploma / GED and 10 years of Science, Engineering, or experience in a related field

**Preferred Qualifications:**

- Masters degree or equivalent in Life Sciences or Engineering.
- Knowledge of GxP, ISO standards, and regulatory expectations for R&D suppliers.
- Experience with supplier quality risk assessment tools and audit practices.
- Working knowledge of computerized system validation and assurance principles, risk-based system lifecycle practices, and applicable expectations for electronic records, electronic signatures, audit trails, and data integrity.
- Experience assessing or overseeing GxP technology suppliers, including software, software-as-a-service, cloud, hosting, infrastructure, implementation, validation, and managed service providers.
- Ability to evaluate supplier audit reports, validation plans and reports, requirements and traceability, testing evidence, security and continuity controls, change records, deviations, CAPAs, and service performance data.
- Experience and proficiency in overseeing AI-enabled GxP systems, including risk assessment, governance, validation, data integrity, and ongoing supplier monitoring.
- Excellent written and verbal communication skills.
- Ability to work effectively in cross-functional teams and in a matrixed environment.
- Strong problem-solving and critical thinking abilities.
- Detail-oriented with a continuous improvement mindset.
- Proactive collaboration and relationship-building skills.
- Ability to manage multiple priorities and deliver results under timelines.

**What you can expect from us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

District of Columbia

R&D Supplier Quality Sr Manager

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**R&D Supplier Quality Senior Manager**

**What you will do**

Lets do this! Lets change the world! R&D Quality has developed a Supplier Quality Oversight capability with the primary objective of delivering a robust, risk-based supplier quality program capable of identifying key leading indicators that predict and prevent critical quality issues.

This role as R&D Supplier Quality Senior Manager will report to R&D Supplier Quality leadership within Precision Medicine, Diagnostics and Supplier Quality (PMDSQ) and will be responsible for the Quality oversight of GxP regulated suppliers and service providers used in the R&D organization, with particular focus on those supporting clinical development activities involving GMP and GDP regulated services This role requires a dedicated professional with a passion for quality management and the ability to identify and execute process improvements, ensuring the highest operational standards.

This role involves establishing and cultivating robust, quality-focused relationships with Amgen suppliers and service providers, contributing risk-based assessments, during supplier evaluation and selection based on applicable regulatory requirements and supplier policies, procedures, and practices, managing related records efficiently and compliantly, and ensuring prompt escalation of high-risk issues to leadership.

A key component of this role will be supporting a cross-functional forum that bridges R&D and Operations to address clinical activities involving GMP/GDP requirements or other situations where responsibilities span GxP or functional boundaries. The Senior Manager will help support risk-based triage, stakeholder engagement, decision-making, escalation, and follow-through when regulatory applicability, supplier qualification requirements, Quality responsibilities, or functional ownership are unclear.

The successful candidate will bring strong practical knowledge and experience in GMP and GDP, complemented by experience within GCP and clinical development, along with strong project management, Quality Risk Management, facilitation, and cross-functional leadership skills.

**Key Areas of Responsibility:**

- Provide risk-based Quality governance and oversight for R&D suppliers, with a focus on hybrid clinical suppliers whose services span GCP, GLP, GPvP, GMP, and GDP-requirements.
- Support and facilitate a cross-functional R&D and Operations forum for clinical quality issues involving GMP/GDP requirements, unclear ownership, or multiple functional stakeholders.
- Coordinate intake and risk-based triage of complex clinical supplier and Quality issues, including identification of applicable requirements, potential Quality and business risks, required subject matter experts, and accountable functions.
- Partner with Quality and business stakeholders to establish fit-for-purpose supplier qualification and oversight strategies when activities cross traditional R&D and Operations boundaries.
- Support the development, negotiation, and maintenance of Quality Agreements and other supplier Quality requirements in collaboration with applicable subject matter experts.
- Collaborate with research and other functions to drive the implementation of continuous improvement initiatives.
- Function as the Quality lead for the execution of quality records related to R&D Supplier management activities
- Define and maintain R&D Supplier Quality KPIs and metrics to identify trends, monitor key signals, and support timely and appropriate action.
- Drive timely escalation, documentation, and continuous improvement for supplier-quality risks, including issues that may affect patient safety, product quality, regulatory compliance, or clinical trial timelines.
- Operate effectively within a global, matrixed organization, coordinating across multiple functions and time zones.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

**Basic Qualifications:**

- Doctorate degree and 2 years of Quality Management or other relevant experience OR
- Masters degree and 4 years of Quality Management or other relevant experience OR
- Bachelors degree and 6 years of Quality Management or other relevant experience OR
- Associates degree and 10 years of Quality Management or other relevant experience OR
- High school diploma / GED and 12 years of Quality Management or other relevant experience

**Preferred Qualifications:**

- Experience in supplier quality management or oversight.
- Working knowledge of GCP, GLP, GPvP, GMP, and GDP regulations, practices, and trends.
- Experience in clinical supply chain Quality or oversight of other GMP/GDP-regulated services used in clinical development.
- Practical experience applying GMP and/or GDP requirements within a regulated life sciences environment.
- Ability to influence and drive progress across functions where direct reporting relationships or clear ownership may not exist.
- Effective and timely decision making and influencing skills executed in a timely manner
- Strong leadership, negotiation, critical thinking and analytical skills
- Skilled in both written and verbal communication for engaging with individuals at all levels within the organization.
- Ability to employ and implement various tools and systems supporting the supplier quality management processes.
- Excellent project management abilities, including coordination of complex cross-functional initiatives.
- Experience working in a global, matrix organization across multiple time zones.
- Experience supporting supplier quality oversight across a complex, cross-functional, or global operating environment.
- Experience in contract negotiations and relationship building with suppliers and service providers.
- Experience in transactional lean, value stream mapping, and identifying areas of process design and improvement.
- Ability to adapt to changing business needs and effectively navigate areas if ambiguity,
- Willingness and capability to travel up to 15%.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Sr. Associate Maintenance Planner

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Sr. Associate Maintenance Planner**

Lets do this. Lets change the world. In this vital role you will report to the Maintenance Manager of the ARI Facilities & Engineering Work Order Planning and Scheduling group. The position is responsible for providing planning and scheduling support at the Amgen Rhode Island site.

**Responsibilities:**

- Work closely with multiple disciplines, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements.

- Support Project Implementation ensuring execution per schedule in accordance with project timelines.

- Work independently to develop the scope of work, resource requirements, and parts requirements to complete preventive and corrective maintenance tasks in a safe, compliant, efficient and effective manner.

- Write clear, concise, and accurate Job Plan steps within the CMMS for corrective and preventive maintenance work orders.

- Clearly communicate with Customers, F&E, Quality and Central Inventory staff regarding work order status and requirements.

- Collaborate with customers and craft groups to schedule maintenance activities as required to support site operations.

- Coordinate maintenance activities into efficient groupings to allow efficient execution by F&E crafts while minimizing the interruption to customer operations.

- Identify and coordinate contractor resources as required to effectively complete tasks.

- undefined

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The driven professional we seek is detail oriented with these qualifications.

**Basic Qualifications**

- Highschool/GED + 4 years of mechanical or utilities related maintenance work experience OR
- Associates + 2 years of mechanical or utilities related maintenance work experience OR
- Bachelors + 6 months of mechanical or utilities related maintenance workexperience OR
- Master'sBachelors degree

**Preferred Qualifications**

- 5 years of experience in a mechanical or utilities related maintenance or maintenance support role or 4 years of experience in a maintenance engineering support role.

- Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs.

- Excellent written and verbal communication skills and the ability to work with minimal direction.

- Excellent organizational skills, attention to detail, and ability to follow up.

- Strong analytical problem-solving skills with a high degree of mechanical aptitude.

- Broad skills and experience with maintenance and operations of plant utility systems and/or process equipment.

- Demonstrated ability to function within cross-functional teams and embrace a team-based culture.

- Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services and GMP Utilities

- Knowledge of work forecasting methods.

- Ability to utilize Microsoft Excel and various database querying tools.

- Demonstrated skills and experience utilizing Maximo to manage maintenance programs.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Rhode Island

Senior Manager, In-Vitro Diagnostics/Precision Medicine Quality

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**SENIOR MANAGER, IN-VITRO DIAGNOSTICS/ COMPANION DIAGNOSTICS/ PRECISION MEDICINE QUALITY**

**What you will do**

Lets do this! Lets change the world! In this remote role you will report to the Director of Precision Medicine and Diagnostics Quality within R&D Quality. This role supports the use of In-Vitro Diagnostics (IVD), including Companion Diagnostics (CDx), within Amgens global clinical trials. This role is responsible for supporting the implementation of a proactive and risk-based Quality strategy for IVD medical devices, including collaborations with diagnostic partners and testing laboratories.

The Precision Medicine and Diagnostic Quality strategy is focused on all aspects of research and development at Amgen, spanning from discovery through the entire lifecycle of clinical development.

**Responsibilities**

- Support quality oversight of IVD medical devices used within Amgens precision medicine and digital medicine clinical trials.
- Provide subject matter expertise on the regulatory and quality oversight of
  IVDs, including CDx, Laboratory Developed Test (LDTs), assays, within the areas of precision and digital medicine.
- Support clinical trial inspections from health authorities (including inspection readiness and managing findings). This includes drug and device inspections.
- Collaborate with Amgens IVD and diagnostic partners to ensure quality oversight of IVDs/ assays used within Amgen drug clinical trials to ensure industry best practices and all regulations are complied with.
- Supports the IVD/ CDx team and collaborators to ensure that IVD/ CDx quality management strategies are advanced related to the evolving and complex IVD regulatory landscape, including the EU and US.
- Provide support for Quality Agreements, clinical trial protocol review, Informed Consent form reviews, IRB application review.
- Provide support for EU Clinical Performance Studies and US IDE requirement implementation.
- Understands and contributes to the collection and use of metrics (KQI, KPI leading and lagging) related to IVD and Precision Medicine for Quality Management System performance and improvement.
- Maintains up-to-date knowledge of IVD regulations and applicable guidance; monitor development of regulations and communicate impact to the business.
- Provides risk-based quality assurance and oversight for IVD/ Precision Medicine activities (e.g., auditing, deviation management and inspection management).
- Ensures that all applicable integrated procedures (e.g., acquired assets) are fit for purpose and aligned to Amgens standards.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

**Basic Qualifications:**

- Doctorate degree and 2 years of quality, regulatory or Companion Diagnostic experience OR
- Masters degree and 4 years of quality, regulatory, or Companion Diagnostic experience OR
- Bachelors degree and 6 years of quality, regulatory, or Companion Diagnostic experience OR
- Associates degree and 10 years of quality, regulatory, or Companion Diagnostic experience OR
- High school diploma / GED and 12 years of quality, regulatory, or Companion Diagnostic experience

**Preferred Qualifications:**

- Experience within the pharmaceutical/ biotech, medical device, and/or biomarker industry working with In-Vitro Diagnostics (IVD) and preferably Companion Diagnostic (CDx) devices.
- Experience at EU clinical trial sites, either as a site monitor or study management.
- Experience working with Companion Diagnostics/ assay development for the pharmaceutical industry/ CLIA cert and/or ISO 15189 cert labs/ biomarker testing.
- Experience working in a quality management system role, or other relevant experience in a clinical research environment that includes quality oversight (e.g., deviation management/CAPA, audit conduct, or inspection support).
- Working knowledge of IVD medical device development (i.e. design controls) and applicable Global Regulations related to use of companion diagnostics and assay development in precision medicine (including EU IVDR, FDA CDx Final Rule).
- An understanding of Precision Medicine and applicable Global Regulations.
- Understanding of EU IVD performance studies under EU IVD Regulation.
- An understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva or TrackWise (Sparta Systems).
- Experience with compliance to GxP requirements including the oversight of third-party vendors, suppliers, and partners.
- Ability to incorporate business and team member feedback into clear, efficient processes using a straightforward language and format.
- Strong analytical, critical-thinking, and decision-making abilities, including development and implementation of Analytics methods and technology in order to enable signal detection and quality improvement.
- Innovative thinking, including the application of quality by design principles.
- Collaborative worker with an ability to support a high performing team.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Associate Quality Assurance

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Associate Quality Assurance**

**What you will do**

Lets do this. Lets change the world. Lets do this. Lets change the world! The role is fully onsite in Thousand Oaks, CA, and requires the ability to lift 30+ pounds and pass a vision assessment for inspection work. Candidates must be comfortable working with raw materials and components, mainly chemicals, and may have to work in the sampling suite ( clean room) for extended periods of time. Previous experience with GMP is a plus but not mandatory, as training can be provided. Candidates of all backgrounds and experience levels will be considered if they demonstrate the right attitude and interest in the role.

**Key Responsibilities:**

- Responsible for sampling and inspection of raw materials and components
- Performing quality review of documentation for assigned functions (e.g. equipment and maintenance records).
- Lead small projects and continuous improvement initiatives.
- Operation and maintenance of instruments and equipment associated with sampling, e.g., Toledo balance, drum lift, pallet jack, etc.
- Maneuvering of large drums required.
- Responsible for the maintenance of training records, recording and computing data.
- Ability to maneuver 50+ pounds
- General understanding of aseptic techniques, cGMPs, gowning, sampling procedures and safety guidelines
- Work as a team player and/or independently
- Multi-task and basic problem-solving skills
- Excellent communication, both written and verbal
- Proficient computer skills (i.e. documentation systems, databases and spreadsheets).
- Strong attention to detail and effective time management skills
- Ability to work alone and lead small continuous improvement projects.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with the following qualifications:

**Basic Qualifications:**

- High school/GED + 2 years of Quality experience OR
- Associates + 6 months of Quality experience OR
- Bachelors degree

**Preferred Qualifications:**

- Bachelors degree
- Prior GMP experience
- Previous experience using production/warehouse equipment
- Familiarity with inspection equipment and lab/ sampling is a plus

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Sr Maintenance Technician / Electrician - Nights

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Sr. Maintenance Technician / Electrician - Nights**

**What you will do**

Lets do this. Lets change the world. In this vital role you will be responsible for performing electrical systems operation and maintenance activities throughout the ARI site.

In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (D shift). This includes extra benefits such as**receiving an added 15% shift differential, and also getting premium pay for any Sundays worked.** The schedule during the initial on-boarding phase for this role (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).

**Job Specific duties include:**

- Operate and maintain electrical power generation and distribution systems
- Operate and maintain backup power / emergency power generation systems and Uninterruptible Power Systems (UPS)
- Perform troubleshooting and repair, and installation of electrical equipment and systems
- Support operation and maintenance of Building Fire Alarm systems including operating the system, disabling points and performing troubleshooting activities
- Perform scheduled and corrective maintenance and repair activities on complex equipment and systems used across the ARI site
- Troubleshoot and repair equipment and systems
- Identify equipment performance opportunities and recommend improvements to the maintenance program owners
- Ensure work activities are completed correctly. Maximize Right the First Time execution.
- Work in a highly productive and efficient manner to maximize the quantity of activities completed
- Ensure work is appropriately communicated to system operators and key stakeholders
- Ensure work order documentation is completed accurately and completely
- Identify waste, workflow interrupters, and other opportunities for improvement, recommend solutions, and assist with implementation
- Identify opportunities to learn new skills and actively participate in development that will
- improve overall team performance
- Ensure activities are accomplished in a safe manner and with quality
- Strict adherence to Standard Operating Procedures (SOPs) and cGMPs
- Ensure work is appropriately communicated to system operators and key stakeholders
- Ensure work order documentation is completed accurately and completely
- Lead by example and create a positive, respectful, professional and consistent work environment always
- Provide on time and accurate communication of issues and updates/reports as necessary
- Flexibility to provide support when required - this may be outside of normal working hours including nights, weekends and holidays

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The detail-oriented professional we seek is a self starter with these qualifications.

**Basic Qualifications:**

- High school/GED + 2 years electrical systems/maintenance work or military experience
- Associates + 6 months electrical systems/maintenance work or military experience

**Preferred Qualifications:**

- Rhode Island Journeyperson Electrician B License, or Journeyperson Maintenance M License or ability to obtain the Rhode Island Electrician License
- 5 + years Electrical and Utilities systems experience and industrial mechanic experience
- Experience with operation and maintenance of industrial electrical generation and power distribution systems (12,470 / 480 / 208 / 120 volts)
- Related education/training of utilities systems
- Experience in pharmaceutical/biotech industry
- Rhode Island Boiler operation knowledge/license
- Knowledge and experience working in a highly regulated function
- Proven equipment troubleshooting skills
- Demonstrated ability to work independently with minimum supervision
- Ability to execute work orders in the Maximo computerized maintenance management system
- Ability to interpret electrical drawings, P&IDs and equipment schematics and wiring diagram
- Effective communication skills (both written and verbal)
- Ability to interact constructively with peers/teams
- Strong computer skills
- Ability to provide guidance and technical advice to others

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Corporate Audit Manager

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Corporate Audit Manager**

**What you will do**

Lets do this. Lets change the world. In this vital role you will support and/or lead Amgen Financial and Operational process audits in the U.S. You may also conduct audits with other Corporate Audit teams covering Anti-Bribery/Anti-Corruption, Healthcare Compliance, Privacy and Third-Party risks. You will also support improvement projects that cover all aspects of internal audit activity.

**Responsibilities:**

- Performing the Annual Audit Plan as approved by the Audit Committee
- Assisting the Senior Managers and Corporate Audit staff in providing independent, objective assurance and consulting services designed to add new value and improve the operations of the Company
- Participating in determining whether Corporate Audits process, document management systems, controls and governance are adequate and functioning in a manner appropriate for a Company of our size and position
- Interacting with Amgens senior and/or mid-level management during engagements
- Exercising sound judgment and initiative in handling business issues of significance to Corporate Audit and the Company
- Assisting on special projects as needed
- Discharging responsibilities in a manner that is consistent with The Institute of Internal Auditors Code of Ethics, International Standards for the Professional Practice of Internal Auditing and Statement of Responsibilities
- Some minimal travel (less than 10% expected)

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The corporate audit professional we seek is a manager with these qualifications.

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and 2 years of Auditing, Accounting, Finance, Compliance or Data Analytics experience

OR

Bachelors degree and 4 years of Auditing, Accounting, Finance, Compliance or Data Analytics experience

OR

Associates degree and 8 years of Auditing, Accounting, Finance, Compliance or Data Analytics experience

OR

High school diploma / GED and 10 years of Auditing, Accounting, Finance, Compliance or Data Analytics experience

**Preferred Qualifications:**

- Degree with an emphasis in Accounting, Finance, Business Administration or Compliance
- 5+ years of related professional experience in Auditing, Accounting, Finance, Compliance or Data Analytics roles
- External audit (e.g., Big 4) and / or internal audit (e.g., Fortune 500) experience
- Proficiency in data analytics, data sensing and/or automation (familiarity with tools such as Tableau, UiPath and Alteryx)
- Advanced certification i.e., CPA / Chartered Accountant, CIA or equivalent
- Experience in auditing controls
- Knowledge and understanding of internal control and risk frameworks
- Pharmaceutical / Biotechnology industry experience
- Knowledge of GAAP, COSO framework, risks, and controls
- Experience in performing Operational (Non-SOX) audits
- Proficiency in SAP and Microsoft Word, Excel, Power Point and Visio
- Ability to work with 'big data' and derive meaningful insights and recommendations
- Self-starter with excellent project management and communication (both verbal and written) skills, including interacting with Amgen senior management effectively and confidentially
- Excellent and insightful analytical skills; ability to be decisive, build teams, and provide leadership
- Excellent discernment (e.g., knowledge of business drivers, finding solutions and knowledge of Accounting, Finance, and other business areas)
- Being able to demonstrate a high level of professionalism and the ability to manage multiple projects simultaneously

**What you can expect from us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Associate Maintenance Technician (Electrical Apprentice)

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Associate Maintenance Technician (Electrical Apprentice)**

**What you will do**

Lets do this. Lets change the world. In this vital role you will be responsible for assisting in the performance of electrical system operation and maintenance activities throughout the ARI site.

**Responsibilities:**

- Support the Amgen Licensed Electricians on daily routine Electrical work
- Assist with the operation and maintenance of backup power / emergency power generation systems and Uninterruptible Power Systems (UPS).
- Perform basic troubleshooting and assist with repair of electrical equipment and systems.
- Support operation and maintenance of Building Fire Alarm systems including assisting with operation of the system and troubleshooting activities.
- Interpret and update loop sheets, electrical schematics, P&ID's, I/O wiring, and panel drawings.
- Ensure activities are accomplished in a safe manner.
- Identify waste, workflow interrupters, and other opportunities for improvement, recommend solutions, and assisting with implementation.

Shift: Admin Shift 6:45A 3:30P (The shift will change to a 12hour rotating day or night shift per Amgens discretion once apprenticeship has been completed)

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a great teammate with these qualifications.

**Basic Qualifications:**

- High School diploma/GED

**Preferred Qualifications:**

- 2 years of electrical maintenance experience
- Associates degree
- Certification that is directly related to the role and 2 years of electrical maintenance experience
- 3+ years of combined education, training, and experience in industrial electric operations andmaintenance and instrumentation/measurement and controls
- Ability and desire to work to obtain Rhode Island Class M Electrician License
- Ability to effectively communicate ideas through verbal and written form
- Effective computer skills
- Ability to interact constructively with peers/teams
- Receptive to guidance and technical advice from others

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.