Manufacturing & Production

IDEAYA Biosciences

Director, Good Manufacturing Processes, Quality Assurance

**Non-Solicitation Policy and Notice to Agencies and Recruiters:**

**IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships**. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.

Job Summary

About IDEAYA Biosciences:

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco, CA.

Position Summary:

We are seeking a Director of Good Manufacturing Processes, Quality Assurance to join our IDEAYA Quality team. The Director, GMP, Quality Assurance will lead GMP QA oversight for drug products and biologics programs from toxicology through Phase 3. This role ensures phase-appropriate GMP compliance across CMC, manufacturing development, and IT Systems, while provided strategic Quality leadership across internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Reporting to: Senior Director, GMP & GDP

Job Description

**What you’ll do:**

· Collaborate to provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards.

· Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase studies.

· Collaborate cross-functionally with Information Technology staff to support computer system validation activities.

· Oversee QA support for development-stage manufacturing, analytical, and including review and approval of deviations, CAPAs, change controls, and protocol/reports.

· Collaborate cross-functionally with CMC staff, Regulatory Affairs, Clinical Operations, and Program Management to drive proactive Quality input into development programs.

· Provide Quality oversight of contract development and manufacturing organizations (CDMOs), and other GxP service providers (vendors) used for clinical trial materials and services. Establish QA-QA relationships and checkpoints for critical CDMOs and service providers.

· Lead or support Quality Agreements, risk assessments, audits, and service provider (vendor) qualification activities to ensure phase-appropriate compliance.

· Actively represent QA in technical development activities, including process development, method validation/transfer, batch record reviews, formulation work, clinical supply chain (including IMP release and product quality resolution), and computer systems validation.

· Collaborate on phase-appropriate quality system improvements for development-stage programs.

· Participate in Quality governance forums, providing expert input on GMP requirements and ensuring alignment with global Quality strategy.

· Support regulatory submissions (e.g., IND, IMPD, BLA sections) by reviewing or contributing Quality input and documentation.

· Create, maintain, and enhance Standard Operating Procedures Governing Development QA activities.

· Support investigations and root cause analysis of product or process issues related to clinical manufacturing.

· Drive Quality input into lifecycle changes, process optimizations, and continuous improvement initiatives across development programs.

· Responsible for final product Quality release/rejection and related processes.

· Support service provider and internal audits as necessary.

· Support oversight of Third-Party Logistics compliance.

· Create and maintain Standard Operating Procedures related to areas of responsibility including product release, design control, change management, technology transfer, etc.

· Host and support regulatory inspections, ensuring inspection readiness and timely resolution of findings. Represent GMP QA in regulatory inspections, partner audits, and due diligence activities.

· Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards.

· Additional responsibilities and duties assigned.

· All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.

· Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

**Requirements:**

· BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred.

· Minimum of 12 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 8 years supporting development-stage programs; advanced degree may substitute for years of experience.

· Minimum 5 years of direct GxP experience (GMP, GCP, GPV, and/or GLP) in a regulated environment supporting small molecule drug products and biologics.

· Minimum 3 years of direct GxP experience supporting computer systems validation.

· Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Part 210/211, 600s, ICH, EU Annexes, GAMP5, ISO 9001, ISO 27001), and compliance expectations across clinical development.

· Demonstrated success in QA oversight of CDMOs, CROs, and testing labs, including audit and service provider management experience.

· Proven track record and relevant industry experience in leading GMP QA functions within a global organization. Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

· Direct experience with clinical manufacturing, analytical method development / validation, tech transfer, and pharmaceutical development.

· Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs.

**Travel required \[Yes / No\]:** Yes

**Percentage of time in a year:** up to 10% per year

**Domestic/International:** Domestic and International

**Physical Demands and 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.

- The employee is required to be on-site in our company offices for a minimum of four days per week.
- The employee will be required to stand and/or walk for up to 3 hours a day and sit for up to 8 hours a day; use hands to handle or feel objects including keyboard and telephones.
- The employee may occasionally lift and/or move up to 15 pounds.
- The noise level in the work environment will vary by location but is usually moderate.

**Lab-based Employees**

· The employee is required to be onsite 5 days per week

· The employee will be required to use their hands to manipulate objects including research chemicals, labware, equipment interfaces, and keyboards both inside and outside of fumehoods, and the employee will be required to carry lab material weighing up to 10 pounds (e.g. racks of solvent-filled test tubes) between fumehoods or between laboratory rooms

· The employee will be required to work while wearing appropriate PPE, including lab coat, protective gloves, and safety glasses

**Total Rewards**

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the roleof Director, Good Manufacturing Processes, Quality Assurance is $200,000 - $247,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite in the office at the Company’s facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

California

Novo Nordisk

Technician II, Engineering - Process

**About the Department**

At Novo Nordisk, we want to make a difference. 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.

Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.

What we offer you:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including **14 paid holidays**
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance
8. Life & Disability Insurance
9. 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**

A Production Technician's primary duty is to provide direct technical support to operations area as it relates to equipment. This role will work collaboratively with multiple functions and departments to ensure equipment and associated production systems operate in a safe, and quality-oriented manner. Responsibilities include: providing training and assessment support for equipment operation, set-up, changeover, and troubleshooting, providing recommendations and implementing solutions to resolve equipment and/or process problems in a timely manner, creating and revising GMP as it relates to equipment activities, supporting or owning work orders and preventative maintenance.

NOTE: This role works 6PM - 6:30AM on a 2/2/3 rotating schedule (Shift B)

**Relationships**

Reports to Manager or Supervisor.

**Essential Functions**

- Complete work under supervision by more experienced team members with increasing independence as experience, training, and job specific aptitude are gained
- Use judgment within generally defined guidelines to identify solutions to problems
- Interact with other departments to schedule activities around the production schedules of the cGMP Manufacturing and Process Development departments. Schedule self-performed work assigned at beginning of month and due by end of month
- Follow general instructions on routine work and detailed instructions of new work
- May design new approaches to problems encountered and use a wide application of complex principles, theories, and concepts in the specific field
- Use hand tools, power tools, and delicate testing equipment in performance of duties
- Complete non-routine repair work orders for regulated and unregulated systems
- Effectively document work performed following required documentation practices
- Be available and respond to site as part of the on-call rotation (optional for Calibration)
- Escort and supervise contractors through facility for routine inspections or repairs, ensuring they complete activities per procedure or agreements
- Perform basic troubleshooting as it related to assigned job duties
- Work with shipping to send out equipment or standard for offsite vendor service and track status
- Contribute to the creation of maintenance and calibration procedures and update existing procedures to match best practices and lessons learned
- Identify and order spare or replacement parts for equipment utilizing inventory management system
- Recommend facility improvements to meet OSHA safety, ISPE, or FDA guidelines
- Opportunity to contribute on Safety Committee, Environmental Engagement Committee, or other corporate responsibility areas
- Assist with onboarding new equipment and retiring obsolete equipment
- Follow all safety and environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 25 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be heating ventilation and air condition controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety engineering practices and procedures will be followed to minimize exposure, including clean room gowning.

**Qualifications**

- High school diploma with at least 3 years of relevant experience
- Intermediate Mechanical and Electrical Skills and Education
- Technical or Associate degree in maintenance related field, preferred
- Must be able to read and understand English-written job instructions and safety requirements
- Technical Requirements:
  - Ability to see and hear, read, and write clear English
  - Mechanical and electrical aptitude
  - Ability to gown for entry in clean room environment
  - Ability to operate within a clean room environment
  - General facility repair, maintenance, and up-keep
  - Ability to understand basic training and apply the knowledge to work activities
  - Ability to apply basic math
  - Ability to use Excel, Word, and other office systems
  - Ability to review data to ensure data is well organized with complete documentation
  - Ability to problem solve and execute/monitor corrective action independently
  - Ability to cross-train on techniques across multiple groups
- Behavioral Requirements:
  - Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner
  - Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time
  - Ability to cooperate with coworkers within an organized team environment or work alone

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.

Indiana

Merck & Co.

Director, Operations - Drug Product (Biologics)

**Director Operations for Drug Product**

Do you aspire to secure a critical role in the production of biologics-based medicines? Are you excited to lead dynamic teams in a state-of-the-art facility that brings transformative biotech treatments to patients globally? We invite you to become a part of our journey as the Director Operations for Drug Product. This role offers you the chance to contribute to the site's development and wield technical leadership to ensure successful GMP manufacturing.

**Principle Roles & Responsibilities / Accountabilities**

- The Director, Operations – Drug Product plays a critical part in strategic project realization of the Wilmington Biotech facility, a new hi-potent facility in our company's Biologic manufacturing network, ensuring that site’s mission and objectives are effectively achieved, consistent with our company's requirements to ensure compliance, safety and reliable supply to our customers.
- As a key member of the Site Leadership Team, you'll have the opportunity to shape site and organizational strategies, overseeing drug product manufacturing for commercial and new product introductions.
- Be part of facility start-up to manufacture high-potent products, eg antibody drug conjugates (ADCs)
- You will work collaboratively with cross-functional teams to streamline technology transfers and commercial approvals, meanwhile nurturing and empowering your operations team.
- You'll get to foster a culture of continuous learning and improvement, leading or supporting various site functional and cross-functional structures for departmental alignment.
- Tackling resource constraints and needs, you will champion operational and technical excellence for efficient production and implement Lean principles for process optimization.
- Upholding our Manufacturing Division Quality Management System (QMS) requirements, you will manage relevant quality topics, and ensure permanent inspection readiness.
- You will oversee financial forecasts and workload for departmental cost improvements, aligning with capital and expense targets while contributing to sustainability and cost reduction initiatives.
- You will have the chance to leverage digital tools for operational efficiency and informed decision-making, keeping pace with emerging digital technologies relevant to manufacturing processes.
- You will be accountable for achieving onsite Key Performance Indicators (KPIs), monitoring and striving to improve performance metrics related to hiring, uptime, training, change controls, investigations, CAPAs, yield, volume, production cadence, operational availability, and more.

**Qualification And Experience**

**Required Experience and Skills:**

- A degree or equivalent in Engineering, Science, Technical, or other relevant fields: Bachelor’s degree + 12 years industry experience Or Masters + 10 years Or PhD + 8 years
- 6 or more years demonstrated leadership ability and experience managing, coaching, and mentoring high-performing cross function teams.
- Demonstrated experience in a biotech/vaccines/pharma manufacturing site, project, or other relevant roles, specifically drug product sterile manufacturing.
- Demonstrated experience in manufacturing clinical and commercial products.
- Understanding of cGMP requirements for commercial high-potent ADC manufacturing of drug product

**Preferred Experience and Skills:**

- Sterile manufacturing leadership & operations, with preferred multi-product experience.
- A leader who inspires, coaches, and fosters a high-performance organizational culture.
- A continuous learner who cultivates a culture of ongoing development within your team.
- An innovative thinker with excellent decision-making and problem-solving skills.
- Experienced in leading highly effective cross-functional teams with a passion for shaping the future of our organization.
- Capable of influencing and building relationships across organizational layers, as well as externally with partners.

Delaware

Associate Director, Technical Operations - Small Molecule Drug Substance

We have an exciting opportunity for an **Associate Director, Technical Operations – Drug Substance** at our Elkton Site in Virginia, USA.

*At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.*

*Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.*

*At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.*

The successful candidate will provide **technical leadership and operational support** for the **startup, technology transfer, validation, and ongoing commercial manufacture** of active pharmaceutical ingredients (APIs).

This role is responsible for **leading technical activities across assigned processes and projects**, supporting the capital project and facility startup phase through to **commercialization and lifecycle management**. The Associate Director will ensure **safe, compliant, and reliable process performance**, while driving continuous improvement and technical excellence.

**Key Responsibilities**

**Technical Leadership**

- Recognized subject matter expert in **Drug Substance process support, and commercial manufacturing**
- Provide **technical oversight and hands-on leadership** for API manufacturing processes, including:
  - Chemical synthesis
  - Purification
  - Crystallization and drying operations
- Support the **Capital Project Team**, contributing to **design, commissioning, qualification, and startup readiness**
- Lead **process scale-up, technology transfer, and validation (pre-PPQ, PPQ)**  activities for assigned processes
- Drive improvements in **process performance, yield, robustness, and impurity control**
- Provide technical guidance on:
  - Process chemistry
  - Reaction performance
  - Critical process parameters and control strategies
- Analyze technical data and **support decision-making for process performance and improvements**
- Identify and escalate risks, proposing **practical, science-based solutions**

**Technology Transfer**

- Lead and execute **technology transfer activities** for assigned processes across internal sites and external partners
- Support development and execution of **tech transfer plans aligned with project timelines**
- Provide technical support for:
  - Raw material evaluation
  - Process fit and manufacturability
  - Scale-up readiness [\[](<https://mydrive.merck.com/personal/egandan_merck_com/_layouts/15/Doc.aspx?sourcedoc=%7BBD8EB341-2E05-49E1-B7A9-A3582FCF916B%7D&file=Elkton%20%20AD%20Drug%20Substance%20JD.docx&action=default&mobileredirect=true>)
- Ensure accurate **process documentation, knowledge transfer, and batch record readiness**
- Support **process validation and continued process verification**

**Operational Excellence**

- Partner with Manufacturing to ensure **safe, efficient, and reliable plant performance**
- Provide direct technical support to:
  - **Campaign preparation, execution, and follow-up**
  - Process troubleshooting during manufacturing
- Lead and support **deviation investigations, OOS, and CAPA**, applying structured root cause analysis
- Monitor **process performance and cycle times**, identifying improvement opportunities
- Drive **continuous improvement initiatives** for yield, cycle time, and cost
- Support **process optimization and debottlenecking activities**

**Regulatory & Compliance**

- Ensure assigned processes operate in compliance with **cGMP and regulatory expectations**
- Support **inspection readiness and audit activities**
- Contribute to **regulatory submissions and responses**, including data generation and technical input
- Ensure **data integrity and adherence to quality and safety standards**
- Maintain compliance from **startup through commercial operations**

**Cross-functional Leadership**

- Collaborate with **Engineering, Capital Projects, R&D, Quality, Supply Chain, and Manufacturing**
- Act as a **technical representative for assigned processes** within cross-functional teams
- Support **technology transfer and process improvements across the network**
- Participate in interactions with **external partners and CMOs** as required
- Contribute to **technical reviews and governance forums**

**People, Capability & Business Leadership**

- Lead and develop a team of **technical specialists and engineers**
- Provide **coaching, technical guidance, and performance feedback**
- Support **resource planning and execution of departmental priorities**
- Contribute to **budget tracking and departmental administration**
- Support **recruitment, onboarding, and capability development initiatives**

**Qualifications**

- Degree (BSc/BEng/Masters) or higher in **Chemistry, Chemical Engineering, or related discipline**
- Significant experience (typically 10+ years) in:
  - **API process development and/or manufacturing**
- Strong background in:
  - Process chemistry and scale-up
  - Process, equipment, and cleaning validation
- Working knowledge of:
  - cGMP manufacturing operations
  - Regulatory expectations and inspection readiness
- Experience with:
  - Deviation management and investigations
  - Electronic batch records and process systems (e.g., DeltaV)
- Exposure to **capital projects, CQV, and facility startup**
- Strong analytical, problem-solving, and communication skills
- Ability to work effectively across **cross-functional teams and multiple priorities**

**Our Culture**

We keep the patient at the heart of everything we do and strive to deliver solutions for some of the world’s most challenging healthcare needs. We believe breakthrough innovation happens when **experienced leaders empower talented teams in an inclusive environment**.

So, if you are ready to:

- **Support delivery of new Drug Substance manufacturing capability**
- **Drive operational and technical excellence in API production**
- **Develop your leadership capability in a high-impact environment**

Virginia

Afton Scientific LLC

Production Manager

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

- Serving clients in 18 Countries
- Successful NDA and ANDA drug registrations
- In good standing with the FDA, PMDA, and MHRA

**NOTE: Afton Scientific does not sponsor work visas. No recruiters please.**

**Position: Production Manager**

**Department:** Operations

**Reports To:** Operations Manager

**FLSA Status:**  Exempt

**Location:**  On-Site – Charlottesville, VA

Afton Scientific is seeking an experienced and highly motivated **Manager, Pharmaceutical Production** to provide leadership and oversight for our pharmaceutical manufacturing operations. This position is responsible for leading production activities, developing employees and frontline leaders, coordinating manufacturing schedules, and ensuring operations are performed safely, efficiently, and in accordance with applicable quality and regulatory requirements.

This is an excellent opportunity for an experienced pharmaceutical manufacturing professional who is ready to take on greater leadership responsibility and play a key role in the continued development of Afton's production organization.

**Compensation**

**$90,000 – $130,000 per year**

Placement within the range will be based on qualifications, relevant experience, internal equity, and demonstrated competencies.

**Primary Responsibilities**

- Provide overall leadership and management of pharmaceutical manufacturing operations.
- Provide direct supervision and guidance to production leadership, including the Supervisor, Pharmaceutical Production and Senior Specialist, Pharmaceutical Production.
- Coordinate production schedules with Sales and Operations to ensure manufacturing activities are completed according to established timelines and customer requirements.
- Oversee day-to-day production activities while remaining capable of providing hands-on manufacturing support when necessary.
- Perform or support production activities, including preparation, equipment setup, aseptic processing, and facility cleaning, as needed.
- Ensure production personnel are properly trained and qualified to perform assigned responsibilities.
- Partner with production leadership to conduct group training sessions and address training needs.
- Mentor and develop Pharmaceutical Operators for increased responsibility and future leadership opportunities.
- Conduct performance reviews and provide ongoing coaching and feedback to production employees.
- Review and approve operator work schedules, as applicable.
- Partner with Quality Assurance to ensure production-floor documentation is completed accurately and on time.
- Coordinate equipment maintenance and validation activities with Facilities and Engineering.
- Write, review, and edit controlled documentation, including SOPs, batch records, reports, specifications, and policies.
- Review and approve quality documentation, including Operational Deviation Reports, Non-Conforming Material Reports, Change Controls, and Problem Analysis and Corrective Action Reports, as applicable.
- Participate in internal audits and support inspection-readiness activities.
- Develop and maintain productive working relationships across Operations, Quality, Engineering, Facilities, and other departments.

**Minimum Qualifications**

- Bachelor's degree desired; Engineering or another technical degree preferred.
- Demonstrated experience in pharmaceutical manufacturing or a related regulated manufacturing environment.
- At least three years of experience leading and developing supervisors.
- Strong understanding of **cGMP requirements** and pharmaceutical production practices.
- Knowledge of aseptic processing, cleanroom operations, and sterile manufacturing practices.
- Demonstrated ability to lead, coach, and develop employees.
- Strong organizational, communication, and problem-solving skills.
- Basic proficiency with Microsoft Word and Excel, with the ability to learn additional database applications.
- Ability to work effectively across departments and manage multiple operational priorities.
- Regular on-site attendance is required.

**Preferred Knowledge and Experience**

- Previous leadership experience within pharmaceutical production or sterile manufacturing.
- Experience supervising production employees and frontline leaders.
- Experience with **aseptic processing and cleanroom manufacturing operations**.
- Experience reviewing or managing deviations, non-conforming materials, change controls, and corrective actions.
- Experience authoring or reviewing SOPs, batch records, reports, specifications, and other controlled documentation.
- Experience supporting internal, customer, or regulatory audits.
- Experience coordinating equipment maintenance and validation activities.
- Demonstrated success developing employees and preparing individuals for increased responsibility or leadership positions.

**Leadership Competencies**

- Leadership & Accountability
- Coaching & Employee Development
- Communication & Collaboration
- Planning & Prioritization
- Operational Excellence
- Quality & Regulatory Compliance
- Problem Solving & Decision Making
- Continuous Improvement
- Talent Development
- Cross-Functional Leadership

**Physical & Work Requirements**

- Ability to work within cleanroom and pharmaceutical manufacturing environments for extended periods.
- Ability to become qualified in proper aseptic gowning.
- Ability to stand for extended periods, bend and reach to access equipment, and lift up to **50 pounds**.
- Ability to work in close proximity to other employees within cleanroom environments.
- Near vision correctable to 20/20, including through corrective eyewear when necessary.
- This is an **on-site position**; remote work is not available.

**What You'll Gain**

- The opportunity to lead and influence Afton's pharmaceutical manufacturing operations.
- Significant responsibility for developing production employees and future frontline leaders.
- Increased exposure to production planning, quality systems, validation, engineering, and cross-functional business operations.
- Opportunities to influence operational effectiveness, training, compliance, and continuous improvement.
- Continued leadership development and career growth within Afton Scientific.

Tris Pharma

Sr. Metrologist

**Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company** focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have \>150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

**Our science and technology make us unique, but our team members set us apart**; they’re the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

**We have an immediate opening in our Metrology department in Monmouth Junction, NJ for an experienced Senior Metrologist.**

The Sr. Metrologist supports Analytical laboratories by performing routine calibration and instrument performance verification, maintenance and repairs on highly complicated instrumentation including, but not limited to: High Pressure Liquid Chromatography/Ultra Performance Liquid Chromatography (HPLC/UPLC), Gas Chromatography (GC), ultra-violet visible spectrophotometry (UV-Vis), Fourier Transform Infrared (FTIR), Muffle Furnace, Viscometers, Density Meters, Melting Point, Dissolution and Autosampler, Polarimeter, ICPMS, GCMS, etc. following analytical methods, United States Pharmacopeia (USP)/National Formulary (NF) Chapters, protocols, Standard Operating Procedures (SOPs) under current Good Manufacturing Practices (cGMPs) and company policies.

Collaborating closely with, and under the direct supervision of laboratory management, the incumbent carries out laboratory work to support laboratory activities and performs special projects as assigned. She/he also writes and assists investigation related to instrument calibration failures or other instrument related issues.

ESSENTIAL FUNCTIONS

• Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws

• Performs routine calibration and instrument performance verification, maintenance, and repairs on highly complicated instrumentation such as HPLC/UPLC, GC, UV-Vis, FTIR, GCMS, ICPMS, Muffle Furnace, Viscometers, Density Meters, Melting Point, Dissolution and Autosampler, Polarimeter etc.

• Processes and reports calibration results using instrument specific data processing software; Documents all activities in legible manner following established formats and good documentation procedures

• Initiates, writes and assists investigation related to instrument calibration failures or another instrument related issues

• Creates, reviews and revises SOPs related to metrology activities

• Initiates change control related to analytical instrument

• Assesses critical analytical instrument/equipment performance

• Executes analytical instrument qualification protocols and drafts qualification reports

• Contacts and obtains technical information from vendors or service providers

• Analyzes samples to evaluate instrumentation performance and troubleshoot instrument malfunction and/or breakdown, etc.

• Trains and mentors lower-level Metrologists and assists them during routine metrology

• Safely and properly dispose of chemical waste, as needed

• Complies with all company policies and procedures, including safety rules and regulations and adheres to cGMPs and current Good Documentation Practices (cGDPs)

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

· Bachelors in Chemistry, Engineering or related scientific field and minimum 6 years lab experience in a GMP related industry or minimum 8 years related experience handling analytical equipment in pharmaceutical or biotechnology industry working in Metrology, Method Validation (MV), Quality Control (QC) or related laboratories **REQUIRED**

· Experience working with Food and Drug Administration (FDA), current Good Laboratory Practices (cGLPs), cGMPs, SOPs and regulatory rules, regulations, and guidelines **REQUIRED**

· Hands on experience performing routine metrology, calibration, maintenance and/or troubleshooting of analytical instrumentation (i.e., HPLC/UPLC, GC, Dissolution Apparatus and Autosamplers, UV-Vis, Density Meter, Balances, Ovens, Viscometers, Melting Point apparatus, Refractometer, Polarimeter, Media Dispenser Ezfill, etc.) **REQUIRED**

· Experience performing or assisting in laboratory or metrology investigations **REQUIRED**

· Previous experience creating, reviewing, or revising SOPs **REQUIRED**

· Proficiency with Empower and/or other laboratory software **REQUIRED**

**Work Arrangements:**  This position requires working in our Monmouth Junction, NJ labs five (5) days per week.

**Anticipated salary range:**  $95 to $115k/yr. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

**Additional benefits:**  In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-office

New Jersey

Eagle Analytical

Inventory Specialist

**Job Details**

**Description**

Position Summary

The Inventory Specialist performs material handling and inventory control activities, including receiving, staging, issuing, and reconciling materials to support laboratory and production operations. This role maintains accurate inventory records, follows established cGMP and regulatory procedures, and executes assigned warehouse tasks to ensure timely and accurate material availability. This role requires frequent movement throughout warehouse, laboratories, and production areas in a fast-paced environment. Employees are expected to be on their feet for the majority of the workday and routinely perform material handling tasks, including lifting, carrying, pushing, and pulling materials. Operation of pallet jacks or similar material handling equipment may be required. This involves transporting supplies to designated locations and fulfilling material or plate orders accurately and efficiently, in accordance with established procedures.

What You Will Do

- Organize daily task flow to ensure efficient, timely warehouse operations and maintain an organized, clean warehouse and related storage areas in compliance with OSHA, FDA, and cGMP standards.
- Prepare and reconcile daily cycle count discrepancies, perform root cause analysis, and report on findings within defined timeframes. Monitor and analyze inventory plans versus actuals, resolving issues related to shortages, overages, and slow-moving or obsolete material.
- Identify and manage minimum/maximum stock levels of materials, ensuring strategic flow into the laboratory and throughout the facility.
- Maintain timely and accurate reporting of inventory (including waste, damage, and discrepancies) and communicate inventory turns monthly to leadership and team members.
- Coordinate with suppliers for level loading of incoming freight and manage item returns. Observe and report on storage and receiving accuracy, investigating and resolving supplier-related discrepancies.
- Collaborate with procurement, supply chain, and production teams to ensure material availability and alignment with production demand.
- Ensure compliance with Eagle Analytical’s Quality Management System (including good documentation practices, accurate recordkeeping, and adherence to training requirements) and all company policies, procedures, and applicable regulations.
- Support departmental goals and contribute to additional projects as assigned.

Who You Are

- Associate’s degree in Supply Chain, Business, or a related field; Bachelor’s degree preferred.
- 3+ years of inventory control or warehouse operations experience, preferably in a regulated environment.
- Experience handling hazardous materials preferred; relevant certification is a plus, or willingness to obtain certification through training
- Knowledge of cGMP, USP, ISO 17025, and FDA regulations.
- Proficiency in ERP systems and MS Office Suite; experience with cycle counting and root cause analysis required.

Physical Requirements

- Ability to lift up to 50 lbs.
- Ability to stand and/or sit for extended periods of time.
- Ability to work at a computer for extended periods, including prolonged screen time.

Who We Are

Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at eagleanalytical.com.

**Qualifications**

**Skills**

**Preferred**

Inventory Management

*Expert*

Follow Specifications

*Expert*

Customer Support

*Advanced*

Collaborating

*Advanced*

**Behaviors**

**Preferred**

Enthusiastic: Shows intense and eager enjoyment and interest

Team Player: Works well as a member of a group

Dedicated: Devoted to a task or purpose with loyalty or integrity

Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well

:

**Motivations**

**Preferred**

Growth Opportunities: Inspired to perform well by the chance to take on more responsibility

Goal Completion: Inspired to perform well by the completion of tasks

Self-Starter: Inspired to perform without outside help

Flexibility: Inspired to perform well when granted the ability to set your own schedule and goals

:

**Education**

**Required**

High School or better.

**Preferred**

Associates or better.

Bachelors or better.

**Experience**

**Licenses & Certifications**

**Preferred**

Prof Cert Sply Ch Mngmt

Equal Opportunity Employer

Texas

Pharmaceutical Operator

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

- Serving clients in 18 Countries
- Successful NDA and ANDA drug registrations
- In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

**Pay Details:**  Non-exempt position, range of $25 - $30 per hour, depending on level of experience.

**_Essential Functions:_**

1. Perform manufacturing processes and operate production equipment, including, but not limited to: washers, autoclave, dry heat oven, heat sealers, vial washer, ultrasonic cleaner.

2. Perform production operations according to Batch Records and Standard Operating Procedures (SOPs)

3. Maintain proper documentation (batch records, production logs, etc.)

4. Write and review master documents as applicable: SOPs and batch records

5. Write Operation Deviation Reports

6. Supervise contract production employees as applicable

7. Maintain inventory of control warehouse space

8. Perform production and maintenance activities in the Aseptic Processing Area (APA)

9. Write and edit documents including: procedures, deviations, master batch records, protocols and reports as necessary

10. Perform initial assembly and review of completed production records for completeness

11. Maintain order and cleanliness in production area

**_Knowledge, Skills & Abilities_**

1. Ability to read and write English. Dress, speak and act in a professional manner

2. Physically able to stand for extended periods of time, mover objects up to 50 pounds, bend and reach to access equipment, have near vision correctable to 20/20 and be able to wear corrective eyewear to achieve this, if necessary.

3. Must be capable of working in close proximity to other employees, regardless of gender, in the confined environment of the production facility.

4. Must be capable of working in the clean room for uninterrupted extended periods

5. Ability to maintain neat and accurate records required

6. Must be able to work with minimal supervision.

**_Requirements for Education and Experience_**

1. Minimum of high school diploma or GED; Associates or Bachelor’s degree desirable

2. One year of manufacturing experience required. Three years manufacturing experience or more strongly preferred.

3. Clean room experience preferred.

Engineering Technician

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

- Serving clients in 18 Countries
- Successful NDA and ANDA drug registrations
- In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

Afton Scientific is seeking a motivated and detail-oriented **Engineering Technician** to join our Engineering team. This position supports engineering, validation, and manufacturing activities through the execution of engineering studies, equipment implementation, process improvement, and hands-on support of sterile pharmaceutical manufacturing operations.

This is an excellent opportunity for an individual who enjoys combining technical expertise with hands-on problem solving in a regulated pharmaceutical manufacturing environment.

**Compensation**

**$31.35 to $38.46 per hour, depending on experience and qualifications**

Placement within the range will be based on qualifications, experience, internal equity, and demonstrated competencies.

**Primary Responsibilities**

- Assist in the execution and reporting of engineering protocols and formal studies.
- Support the evaluation, installation, and qualification of new instrumentation and equipment.
- Evaluate, select, and order parts and components for engineering batches.
- Perform hands-on setup and preparation of sterile pharmaceutical products and components.
- Support validation activities, including equipment setup and execution of validation studies.
- Perform Pharmaceutical Operator II duties as needed to support operations.
- Participate in product and process development initiatives.
- Maintain validation activities in compliance with cGMP requirements.
- Review operational deviations, change controls, validation protocols, and formal studies, as applicable.
- Collaborate effectively with Engineering, Operations, Quality, and other departments to support manufacturing objectives.

**Minimum Qualifications**

- Technical degree, two-year associate degree, or equivalent industry-related experience.
- Basic computer proficiency, including Microsoft Word and Excel, with the ability to learn additional software applications.
- Professional communication and interpersonal skills.
- Ability to maintain positive working relationships with coworkers, supervisors, and vendors.
- Ability to work on-site on a regular basis.

**Preferred Knowledge and Experience**

- Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
- Working knowledge of cGMP requirements and validation principles.
- Experience supporting manufacturing equipment, engineering projects, or validation activities.
- Familiarity with aseptic processing and sterile manufacturing operations.
- Strong mechanical aptitude and troubleshooting skills.
- Ability to work independently while contributing effectively within a cross-functional team.

Amgen

Sr Instrument Technician I

**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.

Sr Instrument Technician

**What you will do**

Lets do this. Lets change the world. In this role the Sr Instrument Technician provides repair and calibration services to support Utilities / Facilities assets and systems. Many of the systems are business critical to Site Operations and must be accurately maintained for compliance and assurance of supply.

- Maintains equipment to ensure uninterrupted service to Amgen

- Performs regular scheduled maintenance / calibration on instruments which support or monitor utility systems (ex. Environmental monitoring, Pressure, Gas detection, Scales, Process equipment, etc.)

- Provides emergency / unscheduled repairs of equipment and plant systems

- Assists with projects by collaborating with system engineers to design, specify, and commission new systems or upgrades

- Responsible for compliance with applicable policies and procedures

- Applies engineering experience to ensure that instrumentation and controls systems used in assigned facilities are accurately specified, installed, programmed, and calibrated to perform design function

- Performs periodic assessment of field device calibration frequencies, and addressing out of tolerance (OOT), accessing instrument performance for replacement / upgrade

- Troubleshoots analog / digital hardware related problems on process control systems and instrumentation, including distributed control systems (DCS), programmable logic controllers (PLC's) and single loop analog controllers

- Performs calibration procedures including training and qualifying calibration technicians

- Effectively communicate, document, and schedule all work activities

- Responsible for maintaining instrumentation and controls equipment in a validated environment including all GxP areas

- Ensures that instrumentation and controls are of appropriate calibration designation and that red tagged and status coded instrumentation are addressed and repaired within allowable time constraints

- Must succinctly communicate the status of job activities to management and applicable production support personnel

- Other responsibilities and duties as assigned by Group Leader, Supervisor, or Senior Supervisor

- Diagnose and resolve issues with automation systems and control equipment.

- Provide technical support and troubleshooting for production and maintenance teams.

- Perform system upgrades and maintenance to ensure optimal performance and reliability.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The technical professional we seek will possess these qualifications.

**Basic Qualifications:**

High school diploma / GED and 2 years of Facilities experience

OR

Associate degree and six months of Facilities experience

OR

Bachelors

**Preferred Qualifications:**

- Associates degree in electronics technology

- Knowledge of validated systems, applicable engineering standards and an ability to work with facility specific software applications is essential to the job function

- Must manage activities to meet restrictive timelines

- Must have strong interpersonal skills including excellent written and verbal communication skills

- Ability to work within and promote a team environment

**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**

**for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

**Sponsorship**

Sponsorship for this role is not guaranteed.

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.

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.

tion.

Ohio

Pharmaceutical Finishing Operator

**Welcome to Your Next Career Chapter**

At **Afton Scientific,**  every role contributes to advancing the quality and reliability of sterile pharmaceutical manufacturing. Our team is driven by innovation, collaboration, and a commitment to excellence. We support employees at every stage of their career by fostering an environment where development, learning, and meaningful impact are possible.

We invite you to explore opportunities to join our organization and contribute to our mission. We are currently seeking a **Finishing Operator** to support our growing manufacturing operations **in Charlottesville, Virginia.**

The Finishing Operator plays a crucial role in ensuring the quality and compliance of our products. You'll be responsible for visual inspections of our sterile liquid medication, along with some labeling, and packaging of products according to established procedures and cGMP regulations under the oversight of the FDA. This is an entry level role ideal for those who are recent graduates or just entering the work force. Training and support provided.

**Compensation**

**$23.00 – $26.00 per hour**

Placement within the range will be based on qualifications, relevant experience, internal equity, and demonstrated competencies.

**Non-Negotiable Requirements:**

• A high school diploma or GED

• Proficiency in Microsoft Word, Excel, and Outlook

• Ability to pass a vision screening and Visual Inspection Qualification testing (can wear glasses/contacts)

**Preferred Requirements:**

• Experience in GMP and FDA-regulated manufacturing environments

• Associate degree or higher

• Familiarity with QA principles and cGMP standards

• Previous experience in pharmaceutical inspection or packaging

**Responsibilities Include:**

• Inspection, labeling and package finished products (sterile liquid medicine)

• Operate Finishing equipment

• Adhere to finishing procedures and PDA guidelines

• Accurately document data and complete any corresponding paperwork

• Contribute to maintaining an FDA-compliant facility

The duties listed above are intended to describe the essential functions of this position. Additional responsibilities may be assigned as needed.

*Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. This role may require sitting, standing, or walking for extended periods; using a computer; and working in a standard office environment. Specific physical or environmental requirements will be addressed through the reasonable accommodation process. We do not discriminate based on disability and will provide reasonable accommodation as required by law.*

Senior Manager Utilities Engineering

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel likeyourepart of something bigger,itsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980,wevehelped 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,youllhelp 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 thatliewithin them,youllthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**Senior Manager Utilities Engineering**

**What you will do**

Lets do this! Lets change the world! The Senior Manager Utilities Engineering will join the Facilities & Engineering (F&E) group reporting to the Facilities & Engineering (F&E) Director. In this vital role, you will lead the Utilities Engineering teams andwill provide technical leadership to the utilities engineering team while supporting 24/7 operations.

Job responsibilities include:

- **Sitedesign, construction, start-up, and operational readiness:**

- Build a team of Utilities Engineers and serve as the main point of contact for the UtilitiesEngineering function.

- Support the start-up of all site utility systems and transfer of ownership to the F&E utilities team.

- Develop and implement long term strategy for technical support of installed systems and equipment including system setups for CMMS, etc.

- Support the development and implementation of goals and objectives and associated budgets for all utility engineering services including but not limited tomechanical and HVAC systems.

- Ensure utility engineering programs are aligned with cGMP and safety requirements, local/ global regulations, and Amgen Maintenance excellence standards.

- Ensure that procedures are in place for cGMP and daily activities are followed by area personnel and contractors.

- Ensure safety of all personnel during plant construction,start-up operations, and maintenance activities across multiple shifts providing 24/7 plant and utility coverage.

- **Site Operations:**

- Responsible for leading the Amgen NC F&E Utility Engineering staff supporting continuous clean and plant utility operations including electrical and HVAC systems at the site.

- Accountable for system ownership for Building and Process utility systems and for supplier management including:

- GMP utilities such as Plant Utilities, Purified Water (PW), Water for Injection (WFI), Clean Steam, Clean Compressed Air, and Process Gases, as well as non-GMP utilities such as waste management, electrical systems, boiler room operations, chilled water systems, plant steam, industrial gases, HVAC systems, and compressed air systems.

- Manage system ownership by providing adequate resources and technical talent and expertise, maintenance procedures, providing adequate system validation support, monitoring performance data, providing adequate training materials, and ensuring operating procedures are followed.

- Develop and support equipment maintenance programs, ensure the availability of spare parts, andcoordinatingmaintenance activities to ensure systems are in proper working order.

- Ensures site readiness and compliance for internal audits, external agency audits, and partner visits.

- Lead and support continuous improvement initiatives including improvements to safety, reliability, efficiency, and sustainability

- Maintain and improve utility system capability and reliability in partnership with engineering leadership and technical staff.

- Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Environmental Health & Safety, and Engineering).

- Have oversight and lead execution of complex Utilities related initiatives and projects. Provide expertise and resources for capital project execution.

- Establish clear expectations and priorities to staff. Encourage a culture of continuous improvement, partnership, and knowledge sharing. Provide development opportunities, feedback, and actively listen to staff.

- Maintain and develop key performance indicators of maintenance performance, supervise, assess, develop staff and ensure that all targets and milestones are completed on time and on budget.

- Participate in the budgeting process for Utilities, including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.

- Up to 10% domestic/international travel

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications:

- Doctorate degree and 2 years of engineering experience

OR

- Masters degree and 6 years of engineering experience

OR

- Bachelors degree and 8 years of engineering experience

OR

- Associates degree and 10 years of engineering experience

Or

- High school diploma / GED and 12 years of engineering experience

And

- 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

- 6+ years experience in Utilityengineeringwithin the biotechnology and/or pharmaceutical or other regulatory environments.

- 3+ years experience of ensuring compliance in a highly regulated environment

- Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment

- Ability to lead multiple tasks and effectively set priorities

- Direct knowledge of GMPutilities such as Purified Water (PW), Water for Injection (WFI), Clean Steam, Clean Compressed Air, and Process Gases, as well as non-GMP utilities such as waste management, electrical systems, boiler room operations, chilled water systems, plant steam, industrial gases, HVAC systems, and compressed air systems.

- Strong knowledge of Computerized Maintenance Management Systems.

- Demonstrated skill in analyzing and improving facilities related quality systems

- Ability and willingness to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.

- Strong leadership, technical writing, and communication/presentation skills.

- Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.

**Thrive**

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising 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 including:

- 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 and bi-annual company-wide shutdowns

- Flexible work models, including remote work arrangements, where possible

**Apply nowfor a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

\#AmgenNorthCarolina

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.

We will ensure that individuals with disabilities are provided reasonable accommodation toparticipatein 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.

North Carolina

AbbVie

Leitung der Herstellung klinischer Prüfpräparate Parenteralia (all genders) (Vollzeit, unbefristet)

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

Herzlich willkommen bei Abbvie! Als Teil eines internationalen Unternehmens mit über 48.000 Mitarbeitern weltweit und rund 3.000 Mitarbeitern in Deutschland hast Du die Möglichkeit, eng mit uns zusammenzuarbeiten, um die gesundheitlichen Herausforderungen von morgen zu meistern. Du hast eine Leidenschaft für die Verbesserung der Gesundheitsversorgung auf der ganzen Welt? Du möchtest Dein Fachwissen einsetzen, um die Lebensqualität von Patienten zu verbessern? In einem herausfordernden Arbeitsumfeld, das Dir die Möglichkeit bietet, Deine eigenen Fähigkeiten zu erweitern und zu entwickeln? Dann bist Du bei uns richtig!

Stell dein Know-how unter Beweis und werde Teil unseres Teams am Standort Ludwigshafen als **Leitung der Herstellung klinischer Prüfpräparate Parenteralia (all genders)**

In dieser verantwortungsvollen Leitungsrolle übernimmst du die stellvertretende Leitung der Herstellung klinischer Prüfpräparate zur parenteralen Anwendung. Du trägst die operative Verantwortung für die GMP gerechte Herstellung und optische Kontrolle von parenteraler Bulkware (Vials und Spritzen) für klinische Studien. Wenn du Expertise in aseptischer Herstellung mitbringst, Freude an Teamführung hast und in einem internationalen, wissenschaftlich geprägten Umfeld wirken möchtest, freuen wir uns auf deine Bewerbung.

**Konkret bedeutet das:**

- Ausübung der Funktion als stellvertretende Leitung der Herstellung gemäß AMG, AMWHV, EU-GMP Leitfaden sowie weiteren relevanten Gesetzen und Regularien einschließlich AbbVie-Vorgaben
- Planung, Durchführung, Überwachung und Bewertung der Herstellung klinischer Prüfpräparate zur parenteralen Anwendung
- Prüfung und Genehmigung von Herstellungsdokumenten
- Prüfung und Genehmigung von Abweichungsberichten, Validierungs- und Qualifizierungsdokumenten
- Bearbeitung von Abweichungen, Ursachenermittlung sowie Festlegen korrektiver und/oder präventiver Maßnahmen (CAPA)
- Verantwortlich für das pharmazeutische Qualitätsmanagement im Verantwortungsbereich
- Verantwortlich für die Aseptischen Prozesssimulationen und die Kontaminationskontrolle
- aktive Mitwirkung bei der Vorbereitung und Durchführung behördlicher Inspektionen und Audits
- Mitarbeit bei der Investitionsplanung und Inbetriebnahme neuer Anlagen
- Mitglied in multidisziplinären Projektteams zur Entwicklung von Arzneimitteln und Herstellungsprozessen
- Führung, Weiterentwicklung und Beurteilung der unterstellten Mitarbeitenden

Qualifications

**So machst Du den Unterschied:**

- Erfolgreich abgeschlossenes Studium der Pharmazie mit Approbation als Apotheker oder vergleichbares naturwissenschaftliches Studium
- Mindestens 5 Jahre Erfahrung im Bereich der aseptischen Herstellung, in der pharmazeutischen Entwicklung oder in einem anderen GMP-regulierten Umfeld
- Mindestens 2 Jahre Erfahrung als Führungskraft
- Fundierte Kenntnisse zu behördlichen Anforderungen und deren Einfluss auf die Arbeitsabläufe und Dokumentationsanforderungen (nationales und internationales Arzneimittelrecht, EU-GMP Leitfaden)
- Business-Englisch in Wort und Schrift
- gute EDV-Kenntnisse
- Strukturierte Arbeitsweise mit hoher Eigeninitiative und Bereitschaft zur Übernahme von Verantwortung
- Hohe Flexibilität und Bereitschaft, sich auf wechselnde Anforderungen in Entwicklungsprojekten einzustellen
- Hervorragende mündliche und schriftliche Kommunikationskompetenzen
- Ausgeprägte Team- und Kooperationsfähigkeit, auch in internationalen und multidisziplinären Teams

**Wie wir gemeinsam Großes bewegen**

- mit einem diversen Arbeitsumfeld, wo Du etwas bewirken kannst
- mit einer offenen Unternehmenskultur
- mit einer attraktiven Vergütung
- mit einem intensiven Onboarding inkl. einem Mentor \*in
- mit flexiblen Arbeitsmodellen für eine gesunde Work-Life-Balance
- mit einem betrieblichen Gesundheitsmanagement mit umfassenden Gesundheits- und Bewegungsprogrammen
- mit betrieblichen Sozialleistungen
- mit vielfältigen Karrieremöglichkeiten in einer internationalen Organisation
- mit hochkarätigen, attraktiven Entwicklungsmöglichkeiten
- mit einem starken, internationalen Netzwerk

Wir wurden mehrfach und weltweit zum „Great Place to Work“ gewählt und sind stolz darauf, unseren Mitarbeitern\*innen die Flexibilität zu bieten, die eine gesunde Work-Life-Balance gewährleistet. Wir nehmen unseren Einfluss auf die Umwelt und die Gesellschaft ernst und konzentrieren und deshalb darauf, regelmäßig etwas zurückzugeben. Wir engagieren uns für Gerechtigkeit, Gleichheit, Vielfalt und Inklusion (EED&I) – das ist von grundlegender Bedeutung für uns. Dazu gehört die Wertschätzung unterschiedlicher Perspektiven, die Schaffung einer integrativen Kultur und der würdevolle und respektvolle Umgang mit allen Mitarbeitern\*innen.

Bei AbbVie zählt Dein individueller Beitrag – Hilf uns, gemeinsam Großes zu bewegen. Sei ein Teil von unserem Erfolg und wachse mit uns – und wachse über Dich hinaus! Klingt wie die perfekte Karrierechance für Dich? Dann freuen wir uns auf Deine Bewerbung. Alles, was Du benötigst, ist ein vollständiger Lebenslauf – alles Weitere besprechen wir dann persönlich mit Dir.

Hast Du noch Fragen? Schicke gerne eine E-Mail an Talentacquisition.de@abbvie.com. Wir freuen uns auf Deine Kontaktaufnahme!

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

Associate Director, Commissioning and Start-Up Engineering (HAZOP)

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

The Associate Director, Commissioning and Start-Up is responsible for providing operational leadership for commissioning, qualification, and start-up activities supporting new manufacturing sites, facilities expansion, utilities, equipment, and related systems. This role ensures assets are delivered safely, compliantly, and on schedule in a state of readiness for GMP operations, while meeting Abbvie quality, operational, and business objectives. The Associate Director leads cross-functional teams and external partners while enabling a smooth transition from project execution to sustained operational performance.

**Key Responsibilities:**

- Provide leadership for commissioning, qualification, and start-up activities across facilities, utilities, equipment, and supporting systems.
- Develop program strategy and lead detailed execution of Hazard and Operability (HAZOP) Studies for all capital programs.
- Develop, align, and execute commissioning and start-up strategies, plans, schedules, protocols, and turnover packages.
- Ensure readiness of systems for GMP operations in compliance with applicable regulatory, quality, safety, and company standards.
- Partner cross-functionally with engineering, validation, manufacturing, quality, EHS, automation, project management, and third-party contractors to deliver integrated startup execution.
- Manage risks, dependencies, timelines, budgets, and issue resolution throughout the project lifecycle.
- Support and oversee site walkdown processes against as built Piping & Instrumentation Diagrams along with Equipment installations to ensure accuracy and operational readiness.
- Lead troubleshooting and corrective action efforts during startup to support successful implementation and stable operations.
- Lead operational readiness and the successful integration of new assets into routine site operations.
- Support budgeting, resource planning, for commissioning and start-up efforts.

Qualifications

- Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical discipline required; advanced degree preferred.
- Typically, 10-12 years20+ years of relevant experience in pharmaceutical or biotech manufacturing and engineering or other highly regulated manufacturing environments.
- Broad experience in commissioning, qualification, start-up, validation, or operational readiness.
- Demonstrated experience leading cross-functional teams. Ability to manage multiple priorities, work through ambiguity, and drive execution in a matrixed organization.
- Strong track record of delivering results in a GMP-regulated environment.
- Strong project leadership, organizational, and communication skills.
- Ability to influence and drive alignment across functions and business units.

**Preferred Qualifications:**

- Experience supporting facility expansions, new product introductions, or major capital projects.
- Experience in sterile injectables, biologics, API, or oral solid dose manufacturing.
- Experience with risk-based CQV methodology and digital turnover systems.
- Prior people leadership experience in a matrixed, global, or highly collaborative environment.

**Leadership Competencies:**

- Strategic leadership
- Enterprise Mindset
- Cross-functional influence
- Accountability and decision-making
- Change leadership
- Operational excellence
- Compliance and quality focus

**Work Environment:** This role may require travel to project and manufacturing sites and extended hours during critical commissioning and start-up phases.

**Key internal stakeholders for an Associate Director of Commissioning and Plant Start-Up typically include:**

- Site Leadership and Site Director – overall site strategy, priorities, and operational readiness
- Engineering Leadership through Director and VP – design execution, utilities, facilities, and project delivery
- Validation / CQV Team – commissioning, qualification, and validation strategy and execution
- Quality Assurance leadership thru Director Level – cGMP compliance, documentation, and release readiness
- EHS (Environmental, Health & Safety) thru Director and VP Level – safe startup, risk controls, and compliance
- Automation / IT / Digital Systems – control systems, data integrity, MES, and infrastructure readiness
- Maintenance / Reliability (MEP) Team – asset readiness, PM strategy, spares, and maintainability
- Project Management / PMO Organization – schedule, scope, budget, and governance
- Procurement / Strategic Sourcing thru Director Level – contractor and vendor management
- HR / Talent / Learning – staffing, training, and organizational readiness
- Finance – budget tracking and capital spend governance

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 long-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

Parts Clean and Prep Associate

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

The Parts Clean and Prep Associate will work in a high-performing and fast-paced pharmaceutical finishing operation to meet our production requirements while maintaining the utmost focus on safety and quality. This role will coordinate and manage the proper cleaning, storage and preparation of solid oral dose pharmaceutical product contact parts and tooling. This individual will contribute directly to the performance of the packaging finishing area by partnering with packaging supervision to plan and ensure that clean product contact parts are available and ready to effectively execute the production schedule across all packaging value streams and shifts.

Responsibilities

- Proactively assess the production schedule with leadership across all shifts to supply clean parts and effectively escalate and/or prevent any production delays.
- Manually clean pharmaceutical product contact parts (e.g. solid oral dose filler and feeder components) and Quality Control count check slides per qualified process.
- Load, operate, and unload the automatic parts washer. Prepare solutions for automatic parts washer and refill alcohol dispensers for all production lines.
- Initiate and fill out equipment cleaning worksheets for pharmaceutical product contact parts in electronic batch management system (POMS).
- Disassemble feeders and properly reassemble them after cleaning is completed.
- Ensure clean parts are available within expiration and documented on Cleaning Tags.
- Accurately follow directions listed in batch records, SOPs, and protocol when performing activities.
- Adhere to Environmental, Health, and Safety and GMP procedures and guidelines, and facilitate a proactive safety culture.

Qualifications

- High school diploma or GED required.
- Previous GMP production related experience preferred.
- 1-2 years pharmaceutical experience preferred.
- Must be able to read and understand production schedules.
- Excellent attendance and punctuality.
- Must be able to work overtime.
- Excellent attention to detail.
- Be able to complete periods of standing or twist and lift activities during shift.

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>)

Director, Engineering, Technical Expert Sterile Fill

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

**Position Summary**

The Director Engineering Technical Expert Sterile Fill provides enterprise-level technical leadership for sterile fill engineering across AbbVie’s strategic investment portfolio, with accountability for biologics sterile filling, Annex 1-aligned contamination control, aseptic processing design, barrier technology strategy, equipment / facility interfaces, GMP readiness, validation / CQV integration and technical assurance within Strategic Investments - Engineering.

The role shapes and governs engineering strategies for strategic investments by setting technical direction, aligning standards and assuring robust execution across priority capital programs, technology platforms and future manufacturing capabilities.

The role leads engineering activities associated with strategic investment programs, including new facility investments, technology platform deployments, capacity expansion, infrastructure enablement, lifecycle asset renewal and capability-building initiatives that materially impact long-term business performance.

The role partners with Strategic Investments leadership, operating sites, quality, EHS, validation / CQV and external engineering partners to make high-quality technical decisions, resolve complex risks and deliver business-aligned engineering outcomes.

Strategic Investments - Engineering Context

Strategic Investments - Engineering provides senior technical leadership, engineering governance, standards ownership and execution assurance across AbbVie’s strategic investment portfolio.

The organization supports strategic capital programs including new manufacturing facilities, technology platform deployments, capacity expansion, infrastructure enablement, lifecycle asset renewal and future capability investments.

Strategic Investments - Engineering roles are expected to establish clear technical direction, drive enterprise alignment, transfer lessons learned and enable consistent, high-quality engineering delivery across the strategic investment portfolio.

**Key Responsibilities**

**Strategic Investments - Engineering Governance and Standards**

- Establish, maintain and deploy global engineering standards, technical practices and governance expectations for biologics sterile fill engineering, Annex 1-aligned contamination control strategy, aseptic processing, barrier technologies, equipment / facility interfaces, GMP readiness, validation / CQV integration and technical assurance.
- Drive consistent application of technical standards, design principles, lessons learned and engineering playbooks across regions, sites and capital projects.
- Ensure discipline strategies directly support AbbVie’s strategic investment priorities, future manufacturing capability requirements and major capital program objectives.
- Provide governance and escalation for technical decisions with material safety, quality, compliance, cost, schedule, operability or lifecycle impact.

**Strategic Investment Leadership and Execution Support**

- Provide senior engineering leadership for strategic capital investments, including new facility builds, technology platform deployments, capacity projects, infrastructure enablement, lifecycle asset renewal and future capability investments.
- Support front-end engineering, facility concept development, investment option evaluation, manufacturing capability assessments and site / platform planning activities.
- Partner with Strategic Investments and project leadership to ensure technical assumptions, deliverables, risks and resource needs are integrated into capital program plans.
- Apply enterprise lessons learned and strategic investment standards to improve project quality, decision speed, reliability and readiness across the portfolio.

**Sterile Filling, Biologics Manufacturing and Annex 1 Compliance**

- Provide senior technical leadership for sterile filling of biologics and parenteral products, including vial, syringe, cartridge and bulk sterile transfer interfaces where relevant to strategic investment scope.
- Ensure facility, equipment and process design decisions are aligned with EU GMP Annex 1 expectations for sterile medicinal products, including contamination control strategy, quality risk management, cleanroom classification, barrier technology and aseptic process control.
- Govern technical strategy for isolators, restricted access barrier systems, Grade A critical zones, Grade B / C / D background environments, unidirectional airflow, first-air protection, glove systems, transfer systems and aseptic interventions.
- Lead engineering input to contamination control strategy development, ensuring critical control points are embedded across facility design, equipment, utilities, personnel flows, material flows, cleaning, disinfection, environmental monitoring and maintenance access.
- Partner with Quality, MS&T, Validation / CQV and Operations to ensure aseptic process simulations, media fill strategy, filter integrity testing, sterile filtration, container closure integrity, environmental monitoring and viable / non-viable particle control are considered in design and readiness decisions.
- Provide technical challenge and risk-based decision support for interventions, line set-up, lyophilization interfaces, stopper / component handling, depyrogenation, sterilization, single-use systems, CIP / SIP interfaces and biologics product protection requirements.
- Ensure sterile fill investment programs are designed for inspection readiness, robust contamination prevention, operational maintainability, product sterility assurance and reliable long-term biologics manufacturing performance.

**Technical Leadership and Delivery**

- Lead technical decision-making for biologics sterile fill engineering, aseptic processing design, Annex 1 compliance expectations, contamination control strategy, barrier technology selection, equipment / facility interfaces, GMP readiness, validation / CQV integration and technical assurance across strategic investment programs and technology platforms.
- Ensure engineering deliverables support safety, quality, compliance, operability, maintainability, reliability, sustainability and operational readiness.
- Coordinate technical input from project teams, site SMEs, external engineering partners, vendors and cross-functional stakeholders.
- Drive timely resolution of technical issues and ensure disciplined escalation when decisions have material project, portfolio, enterprise or business impact.

**Cross-Functional Integration**

- Partner with Strategic Investments, manufacturing operations, quality, validation / CQV, EHS, site engineering, MS&T, supply chain, finance and related engineering disciplines.
- Ensure discipline decisions are integrated with strategic investment objectives, manufacturing strategy, capacity planning, technology platform deployment, regulatory expectations and site handover needs.
- Facilitate collaboration across regions, sites and project teams to avoid fragmented solutions and drive consistency across strategic investments.
- Represent Strategic Investments - Engineering in technical reviews, project forums and risk discussions relevant to assigned scope.

**Capability Building and Continuous Improvement**

- Share engineering best practices, lessons learned and technical knowledge across sites, regions and projects.
- Build capability through coaching, mentoring, technical review discipline and development of reusable engineering practices.
- Promote a culture of engineering excellence, safety, quality, reliability, collaboration, accountability and proactive risk management.
- Support continuous improvement of Strategic Investments - Engineering standards, templates, knowledge management and project delivery approaches.

**Strategic Investments - Engineering Leadership Expectations**

- Collaborate across the enterprise engineering community to identify, develop and deploy best practices, technical standards, lessons learned and capability-building initiatives.
- Promote consistency, quality, reliability, sustainability and project delivery performance across the strategic investment portfolio.
- Support long-range strategic investment planning, manufacturing strategy and future capability development.
- Build technical capability through coaching, mentoring, standards governance, knowledge management and cross-functional collaboration.

**Stakeholder Interfaces**

**Strategic Investments:** Investment planning, portfolio alignment, technical assumptions, front-end engineering, strategic capital program support and executive decision enablement.

**Manufacturing Sites and Operations:** Network needs, site readiness, operability, maintainability, startup, handover and operational performance support.

**Quality, Validation / CQV and EHS:** Compliance expectations, validation strategy, qualification readiness, safety, risk review and inspection readiness interfaces.

**Strategic Investments - Engineering Disciplines:** Cross-discipline technical integration, standards, design reviews, technical issue resolution and strategic investment lessons learned.

**External Engineering Partners, EPCM Firms, Vendors and OEMs:** Technical oversight, deliverable review, issue escalation, supplier alignment and execution quality.

Qualifications

- Bachelor’s degree in Engineering, Science or a relevant technical discipline required; advanced degree preferred where relevant.
- Typically 12+ to 15+ years of relevant engineering, manufacturing, capital project, technical operations or regulated manufacturing experience.
- Demonstrated technical capability in biologics sterile filling, aseptic processing, Annex 1 contamination control expectations, isolators / RABS, cleanroom interfaces, sterile filtration, environmental monitoring, GMP readiness, validation / CQV integration and technical assurance.
- Experience supporting pharmaceutical, biopharmaceutical, medical device, API, peptides, biologics, sterile or similarly regulated manufacturing environments preferred.
- Demonstrated ability to operate across global functions, strategic investment teams, manufacturing sites, project teams, suppliers, vendors and external engineering partners.
- Strong communication, risk management, technical judgment, stakeholder engagement and structured problem-solving skills.

**Technical Competencies**

- Biologics sterile fill-finish systems
- EU GMP Annex 1 contamination control strategy, aseptic processing and sterility assurance
- Equipment / facility interfaces
- Strategic investment portfolio support
- Strategic investment manufacturing readiness and sterile operations support
- Strategic capital investment leadership
- Engineering governance and standards
- Technical risk management
- Project execution support
- Stakeholder management
- Vendor / partner technical coordination
- GMP and regulated manufacturing awareness
- Isolator / RABS design, Grade A critical zones, background classification and aseptic intervention strategy
- Operational readiness and handover support

**Leadership Competencies**

- Strategic thinking and enterprise mindset
- Matrix leadership and influence without direct authority
- Clear technical communication and executive-ready recommendations
- Risk-based decision making and issue escalation
- Collaboration across functions, sites, regions and external partners
- Capability building, mentoring and knowledge sharing
- Continuous improvement and commitment to safety, quality and compliance

**Working Relationships**

This role works globally with Strategic Investments, Strategic Investments - Engineering disciplines, manufacturing sites, quality, validation / CQV, EHS, operations, MS&T, supply chain, finance, external engineering firms, technology vendors and equipment suppliers. The role is expected to operate as a senior technical leader across multiple strategic investment programs and technology platforms, setting direction, strengthening technical governance and enabling high-quality capital delivery.

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 long-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>)

Director, Engineering, Utilities & Electrical

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

**Position Summary**

The Director, Utilities & Electrical owns strategic discipline leadership, people leadership, technical governance and project enablement for electrical power systems, clean utilities, black utilities, energy infrastructure, reliability, maintainability, electrical safety and operational readiness within AbbVie Global Engineering.

The role provides senior technical and organizational leadership for AbbVie’s global manufacturing network and strategic capital investments through standards ownership, front-end engineering support, technical decision-making, project risk management and disciplined execution across priority investment programs, manufacturing sites and technology platforms.

The Director leads and develops a global team of electrical and utilities technical experts, establishes clear priorities and accountabilities, and ensures the organization has the capability and capacity required to support brownfield expansions, modernization programs, debottlenecking, infrastructure upgrades, lifecycle asset replacement and greenfield manufacturing investments.

The role serves as the senior Global Engineering authority for electrical and utilities strategy, ensuring systems are safe, compliant, resilient, energy efficient, maintainable and capable of supporting current and future manufacturing requirements.

The Director partners with Strategic Investments, project delivery teams, operations, quality, EHS, validation/CQV, site engineering, sustainability, digital/automation and external engineering partners to deliver technically robust, scalable and business-aligned engineering solutions.

**Global Engineering Governance and Standards**

- Establish, own and deploy global engineering standards, design criteria, specifications, technical practices and governance expectations for electrical power systems, clean utilities, black utilities, energy infrastructure, reliability, maintainability and electrical safety.
- Act as the senior discipline authority for material electrical and utilities decisions affecting safety, quality, compliance, cost, schedule, operability, resilience or lifecycle value.
- Define discipline strategy and multiyear capability roadmaps aligned with AbbVie’s manufacturing network strategy, sustainability objectives and strategic investment priorities.
- Govern consistent application of standards, design principles, lessons learned and engineering playbooks across regions, sites and capital projects.
- Establish assurance and review processes that verify technical quality at key project stage gates.
- Lead resolution and escalation of significant discipline risks, deviations from standards and cross-project technical issues.
- Represent Global Engineering in enterprise technical governance forums and communicate clear, executive-ready recommendations to senior stakeholders.

**Strategic Capital Investment Leadership**

- Provide senior owner-side engineering leadership for the electrical and utilities scope of strategic capital investments, including new facilities, major capacity programs, technology platform deployments, infrastructure solutions and lifecycle asset strategies.
- Lead discipline input to front-end engineering, facility concepts, site master planning, investment option evaluation, business cases and technology selection.
- Define electrical and utilities design strategies for strategic projects, including power architecture, utility generation and distribution, redundancy philosophy, capacity planning, energy performance, maintainability, monitoring and operational readiness.
- Ensure discipline assumptions, deliverables, risks, interfaces, resources and decisions are incorporated into program plans, cost estimates and execution strategies.
- Establish project assurance priorities and direct senior technical reviews at concept, basic design, detailed design, construction, commissioning and handover stages.
- Balance safety, quality, compliance, reliability, sustainability, cost and schedule when making or recommending investment decisions.
- Apply global lessons learned and network standards to improve project quality, speed, predictability and readiness across the portfolio.
- Provide clear escalation to the VP, Global Engineering and Strategic Investments leadership when decisions have material enterprise, program or network impact.

**Electrical and Utilities Technical Leadership**

- Lead technical decision-making for medium- and low-voltage power distribution, substations, transformers, switchgear, motor control, emergency and standby power, uninterruptible power supplies, grounding, lightning protection and electrical protection systems.
- Provide governance for electrical safety, arc-flash risk, hazardous-area classification interfaces, protection coordination, power quality, system studies and safe equipment lifecycle management.
- Direct strategies for clean utilities, including purified water, water for injection, clean steam, process gases and associated generation, storage, distribution, monitoring and sanitization systems.
- Direct strategies for black utilities, including plant steam, chilled water, cooling water, compressed air, nitrogen, natural gas, wastewater and other supporting infrastructure.
- Set expectations for system capacity, redundancy, resilience, reliability, maintainability, energy efficiency and future expansion.
- Ensure electrical and utilities systems are appropriately integrated with process, HVAC, mechanical, civil, structural, automation, instrumentation and building-management systems.
- Oversee technical reviews of load lists, single-line diagrams, utility balances, capacity models, equipment specifications, vendor packages, design calculations and commissioning strategies.
- Ensure engineering deliverables support GMP compliance, validation/CQV, safe operation, maintainability, sustainability and effective site handover.
- Drive timely resolution of complex technical issues and ensure decisions are documented, risk assessed and communicated.

**People Leadership and Organizational Capability**

- Lead, develop and retain a high-performing global team of electrical, clean-utilities and black-utilities technical experts.
- Set clear direction, priorities, objectives and performance expectations aligned with Global Engineering and Strategic Investments priorities.
- Allocate technical resources across programs and sites based on business criticality, project risk, specialist capability and portfolio demand.
- Coach and mentor technical leaders and subject-matter experts, strengthening technical judgment, leadership capability and succession readiness.
- Establish structured development plans, knowledge-transfer mechanisms and succession plans for critical electrical and utilities capabilities.
- Build an inclusive, accountable and collaborative culture focused on engineering excellence, safety, quality and reliable delivery.
- Clarify decision rights and interfaces between Global Engineering, site engineering, project teams and external partners.
- Use external engineering partners and specialist resources strategically while retaining effective owner-side knowledge and governance.

**Portfolio, Delivery and Partner Governance**

- Provide discipline oversight across multiple concurrent projects, manufacturing sites and technology platforms.
- Establish portfolio-level visibility of significant technical decisions, design maturity, risks, resource constraints and assurance findings.
- Work with project leadership to define discipline deliverables, review schedules, staffing needs and escalation routes.
- Hold external engineering partners, EPCM firms, vendors and OEMs accountable for technical quality, standards compliance and timely resolution of issues.
- Support sourcing strategies, framework agreements, vendor qualification and technical bid evaluations for key electrical and utilities equipment and services.
- Review supplier performance and lead corrective action where technical quality, schedule, documentation or execution does not meet expectations.
- Ensure effective transition from project delivery to commissioning, qualification, operational readiness and sustained manufacturing support.
- Promote predictable delivery through standardization, reusable designs, disciplined change control and early risk identification.

**Cross-Functional and Enterprise Leadership**

- Partner with Strategic Investments, manufacturing operations, quality, validation/CQV, EHS, site engineering, MS&T, supply chain, finance, procurement, sustainability, digital/automation and related engineering disciplines.
- Ensure electrical and utilities decisions are integrated with manufacturing strategy, network capacity, regulatory expectations, technology deployment and site handover requirements.
- Influence senior stakeholders across functions, regions and sites to achieve aligned enterprise outcomes.
- Facilitate collaboration across projects and sites to prevent fragmented solutions and unnecessary technical variation.
- Represent Global Engineering in technical reviews, investment forums, risk discussions and program governance relevant to the assigned scope.
- Communicate complex technical matters in clear business terms, including implications for safety, compliance, investment, schedule, resilience and lifecycle performance.

**Global Engineering Leadership Expectations**

- Operate with an enterprise mindset and make decisions that optimize outcomes across the manufacturing network rather than for an individual project or site.
- Translate business and manufacturing strategies into discipline priorities, technical roadmaps and executable plans.
- Demonstrate visible leadership for safety, quality, compliance, integrity and engineering excellence.
- Provide clear direction in ambiguous or high-risk situations while appropriately engaging specialists and senior stakeholders.
- Build trusted relationships with executives, site leaders, project leaders and external partners.
- Develop organizational capability through coaching, performance management, succession planning and intentional deployment of talent.
- Challenge technical assumptions constructively and ensure important risks and trade-offs are transparent.
- Promote standardization, innovation, sustainability, knowledge sharing and continuous improvement across the global network.
- Hold teams and partners accountable for commitments, technical quality and timely delivery.

Qualifications

- Bachelor’s degree in Electrical Engineering or a closely related engineering discipline required; master’s degree or relevant professional qualification preferred.
- Typically 15 or more years of progressive experience in electrical engineering, utilities engineering, manufacturing engineering, capital projects or technical operations, including significant leadership responsibility.
- Extensive experience in pharmaceutical, biopharmaceutical, API, peptide, biologics, sterile or similarly regulated manufacturing environments.
- Demonstrated experience leading electrical and utilities engineering scope for major brownfield and greenfield capital investments.
- Proven experience leading and developing technical professionals, establishing priorities, managing performance and building organizational capability.
- Demonstrated ability to direct multiple projects, sites, workstreams and external engineering partners in a global matrix organization.
- Strong technical knowledge of industrial electrical power distribution, emergency power, electrical safety, reliability, power-system studies, clean utilities and black utilities.
- Working knowledge of GMP, EHS, validation/CQV, commissioning, operational readiness and regulated asset lifecycle requirements.
- Strong commercial and financial acumen, with the ability to assess technical alternatives, lifecycle value, capital cost, operating cost and business risk.
- Demonstrated ability to make risk-based decisions, influence senior stakeholders and provide concise executive recommendations.
- Experience governing EPCM firms, design partners, equipment vendors, utilities specialists and construction or commissioning organizations.
- Strong communication, negotiation, stakeholder management, talent development and structured problem-solving skills.
- Ability to travel globally to manufacturing sites, engineering partners, suppliers and strategic project locations as required.

**Technical Competencies**

- Medium- and low-voltage power distribution
- Substations, transformers, switchgear and motor-control systems
- Emergency power, standby generation and uninterruptible power supplies
- Grounding, lightning protection, electrical protection and coordination
- Electrical safety, arc-flash risk and hazardous-area interfaces
- Power quality, load studies, capacity planning and system resilience
- Clean utilities generation, storage, distribution and monitoring
- Black utilities generation and distribution
- Utility balances, redundancy philosophies and lifecycle strategies
- Energy efficiency, sustainability and infrastructure decarbonization
- Reliability, maintainability and asset-management strategy
- GMP engineering, validation/CQV and operational readiness
- Global engineering standards and design governance
- Front-end engineering and strategic capital investment support
- Vendor, EPCM and external engineering-partner governance
- Technical risk management and executive decision support

**Leadership Competencies**

- Enterprise and strategic leadership
- Direct and matrix people leadership
- Talent development, succession planning and performance management
- Portfolio prioritization and resource deployment
- Executive communication and influence
- Risk-based decision-making
- Accountability for technical and project outcomes
- Cross-functional and global stakeholder leadership
- Partner and supplier governance
- Change leadership and organizational capability building
- Financial and commercial judgment
- Commitment to safety, quality, compliance and continuous improvement

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 long-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>)

Manager Engineering (12 Hour Shift - 6AM to 6PM)

**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.

Engineering Manager

**What you will do**

Lets do this. Lets change the world. In this role, the Manager of Engineering is responsible for maintenance support assignments at Amgens manufacturing site in Ohio. The position is a key role in the Engineering group and the candidate must manage and/or apply extensive technical expertise in the coordination of multiple, sophisticated, non-routine maintenance tasks of systems.

**Engineering & Maintenance Management**

- Key responsibilities will include providing engineering and maintenance services and support to pharmaceutical packaging lines.

- Lead a team of experienced maintenance and engineering personnel across Amgen commercial operations for product assembly, label, and packaging.

- The position is expected to bring to bear this team to support equipment maintenance, trouble shooting, triages, and process improvements.

- Ensure on-the-floor support of engineering and maintenance to reduce production downtime. Provide leadership and technical expertise for maintenance strategy for equipment and systems.

- Recommend and support improving maintenance instructions, including but not limited to Job Plans, Spare Parts Lists and PMs.

- Own selected maintenance SOPs and recommend and implement improvements. Recommend and implement improvements to the timing and coordination of maintenance activities. Provide field support to identify and resolve equipment and maintenance-related issues.

- Provide support to improve safety, compliance, efficiency, and effective execution of maintenance work orders.

- Evaluate equipment and instrumentation maintenance and failure history and recommend and implement improvements.

- Manage selected maintenance contract service providers.

- The Engineering Manager is tasked with facilitating effective communication across the Amgen commercial site network by utilizing all collaborators and delivering on technical improvements.

- Site communication will occur during daily Tier meetings, escalation processes, and vendor coordination, among other methods, to engage all team members and achieve technical advancements in communication, etc.

- This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations in the Amgen Ohio manufacturing facility.

The Engineering Manager position works with the Senior Manager of Engineering at the Amgen Ohio facility.

The position is expected to travel approximately 15%.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

**Basic Qualifications:**

- Masters degree in e**n**gineering or related discipline & 3 years of related experience

- Bachelors degree in engineering or related discipline & 5 years of related experience

- Associate degree in Engineering or related discipline & 10 years of related experience

- High school diploma / GED & 12 years of related experience

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Educational background in Mechanical Engineering, Mechatronics, or related technical degree

- Experience repairing mechanical equipment in a manufacturing environment (experience with packaging equipment preferred)

- Strong mechanical proficiency and trouble shooting skills

- Understanding in PLC, Computer Serialization, Packaging Equipment, Vision Inspection System (Cognex Vision System and Systech Serialization)

- Excellent organizational, project management, problem solving and technical writing capability

- Strong communication: verbal / written, collaboration, influencing and facilitation

- MS Office: Word, Excel, Power Point

**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**

**for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

**Sponsorship**

Sponsorship for this role is not guaranteed.

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.

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.

Manager Engineering - (12 Hour Shift - 6PM to 6AM)

EH&S 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.

**Environmental Health and Safety Manager**

**What you will do**

Lets do this. Lets change the world. In this vital role you will be responsible for the implementation, coordination, advancement and support of environmental compliance and sustainability programs at the site level. The candidate may also be asked to provide broader EHS support to Research & Development and/or Product Development staff.

**Functions (Duties/Accountabilities) Environmental:**

- Interpret complex environmental regulations and maintain, improve or develop processes that will ensure Best-In-Class compliance with Federal, State and local requirements;
- Monitor proposed legislation, rule changes and rule-making processes; evaluate and determine applicability to site operations and activities and develop compliance plans and programs as needed;
- Interface with regulatory authorities, including proactive and regular communications to address environmental compliance and sustainability program needs and accompanying agency representatives during on-site inspections;
- Prepare and submit internal and external regulatory analyses, compliance audits and reports within expected timeframes, by or before reporting deadlines;
- Identify opportunities to improve environmental compliance programs and reduce environmental impacts (waste/water/carbon) by utilizing data analytics, benchmarking and internal program audits/evaluations and develop projects, programs and action plans to drive continuous improvements;
- Lead data collection, validation and submission to support sustainability metrics reporting;
- Maintain appropriate records and documentation needed to ensure and demonstrate compliance with applicable environmental rules, regulations and requirements;
- Development, delivery and/or facilitation of training.

**Functions (Duties/Accountabilities) Health and Safety:**

- Act as an EHS single point of contact for internal client organizations and engage EHS subject matter experts as appropriate;
- Conduct regular laboratory and other work area/activity inspections, ensure changes with potential EHS impacts are assessed, investigate incidents and proactively assess risks related to routine and non-routine activities;
- Partner with all levels of internal client and site/corporate EHS functions to execute the EHS culture program;
- Support emergency response activities including responding to hazardous material spill/release and/or exposure events and participating in emergency response exercises and training.

**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 detail-oriented self-starter with these qualifications.

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and 3 years of **Environmental Health and Safety experience**

OR

Bachelors degree and 5 years of **Environmental Health and Safety experience**

OR

Associates degree and 10 years of**Environmental Health and Safety experience**

OR

High school diploma / GED and 12 years of **Environmental Health and Safety experience**

In addition to meeting at least one of the above requirements, you must have experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Experience with environmental and EHS management systems.
- Experience with programs related to hazardous materials storage and transportation, water quality, regulated waste, air quality and/or environmental sustainability.
- Experience interfacing with regulatory agency representatives during on-site inspections and to address program needs.
- Current qualification as a Hazardous Material Technician under the Federal HAZWOPER standard;
- Action-oriented, self-starting program development and project management capabilities.
- Advanced skills working with MS Excel.
- Demonstrated experience learning and working with data sets/databases, reporting portals and software packages.

**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.