Quality

Civica Rx

QA Ops Shop Floor Specialist (412)

**Position Summary:**

The Quality Assurance Operations Shop Floor Specialist is part of the Quality Assurance Operations team at Civica’s Petersburg, Virginia manufacturing facility. The Petersburg site serves as Civica’s new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. This role will function as the most senior member of the Quality Assurance Operations Shop Floor team, interacting with other cross-functional teams to provide oversight of manufacturing operations. The goal of this role is to ensure accuracy, compliance, efficiency, and safety in all aspects of site operations.

**Key Responsibilities:**

- Identify departures from approved procedures & respond to complex issues independently & escalate critical issues to management.
- Develop, review and/or approve temporary and non-routine procedures for event response.
- Observe manufacturing operations and identify departures from proper clean room behaviors, aseptic techniques, and gowning procedures.

- Coordinate and lead area walkthroughs to identify quality issues. Work cross-functionally to create remediations and drive alignment of implementation plans.
- Own actions for departmental programs and propose improvements to programs.
- Communicate and resolve discrepancies independently and escalate as required.
- Author and review procedural documents.
- Provide guidance and training for floor personnel.
- Assess discrepancies for entry into quality system and initiate deviations as applicable.
- May serve as a Quality Assurance subject matter expert for site-wide assessments.
- Lead meetings and represent Quality Assurance function at cross-functional meetings.
- Share data/knowledge within and across partnering teams, all while building & maintaining strong relationships within the quality culture.
- May prioritize and assign tasks for the Quality Assurance Shop Floor team.
- Observe operations occurring on the floor and proactively identify risks and drive improvements.
- Should be familiar with GMP-related management systems including quality documentation, supplies, and equipment.

**Basic Qualifications and Capabilities:**

- Bachelor's degree or above in a scientific discipline.
- Minimum of 4+ years of experience within a pharmaceutical, biotech, cell therapy, or medical device cGMP-regulated manufacturing environment.
- Experience in sterile pharmaceutical isolator technology, combination products, or medical devices.
- Demonstrated experience delivering training on cGMP regulations, standard operating procedures (SOPs), and quality systems.
- Ability to research, understand, interpret, and apply internal SOP’s, policies, and regulatory guidelines.
- Proficient computer skills with knowledge of digital tools such as MS Office and ability to learn and work with new software applications.
- Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
- Excellent written and verbal skills and ability to present technical data effectively based on the target audience.
- Ability to work in a fast-paced team environment and lead peers through changing priorities.
- Detail-oriented and task-focused with the ability to meet deadlines and support work prioritization.

- Exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
- Demonstrated experience with quality management systems used to compliantly handle records such as change controls, deviations, investigations, as well as corrective and preventative action (CAPA) management.

**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 position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities this position requires include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, a drug-free workplace, and complies with ADA regulations as applicable.

Virginia

Manager, Quality Engineering (215)

This role provides independent Quality oversight and governance of engineering, manufacturing, and technical support activities. This role ensures that outputs generated by Operations, Facilities & Engineering, and MSAT meet cGMP, regulatory, and internal quality standards. The position is responsible for the review and approval of QMS records, investigations, protocols, technical reports, and system deliverables.

The Manager plays a key role in maintaining a robust Quality Management System (QMS) and ensuring inspection readiness, supporting the reliable supply of high-quality sterile injectable and combination products.

**Essential Duties and Responsibilities:**

· Provide leadership, direction, and support to the people within Quality Engineering and other departments to ensure that they are qualified to achieve a high level of competence, are motivated, and carry out their duties in a safe manner.

· Establish and maintain the site’s quality system processes related to GMP compliance of the facility, equipment, computer systems and manufacturing processes by working across functions.

· Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality-related matters are provided to the site.

· Provide Quality oversight for documentation supporting combination product and device-related activities. Ensure compliance with applicable regulatory expectations (e.g., 21 CFR Part 4 where applicable).

· Review and approve transfer-related documentation to ensure completeness, traceability, and compliance. Ensure alignment between sending and receiving site documentation.

· Oversee and approve maintenance records, calibration records, and system outputs for compliance and data integrity within the Computerized Maintenance Management System (CMMS).

· Provide quality oversight for calibration and maintenance programs and ensure they are developed and run in accordance with GMP regulations.

· Review and approve protocols, reports, and investigations associated with automated inspection systems.

· Review and approve deviations and investigations related to engineering systems, utilities, equipment, and manufacturing operations.

· Ensure root cause analysis, impact assessments, and CAPAs are appropriate and effective.

· Oversee trending reports and quality metrics generated by technical and operational functions as it relates to the Quality Engineering oversight.

· Ensure data is accurately trended and supports effective decision-making and continuous improvement.

· Review and approve documentation related to automation systems, ensuring appropriate controls, traceability, and compliance.

· Review and approve change controls impacting facilities, utilities, equipment, systems, and processes.

· Ensure changes are appropriately assessed for impact, risk, and regulatory compliance

· Support operational and inspection readiness for Health Agency inspections.

· Support quality processes and systems across the product lifecycle, including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.

· Participate in or lead quality risk analysis/assessments.

· Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.

· Lead and participate in deviation investigations as necessary.

· Promote a quality mindset and quality excellence approach to all activities.

· Promote a safety mindset and focus on safety for all operational activities.

· Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.

· Participate in and/or lead health authority (primarily FDA and E.U.) agency inspections at the site.

**Basic Qualifications and Capabilities:**

· Bachelor’s degree in a scientific discipline with a minimum of 10 years of Quality/cGMP experience. Experience in facility, utilities, and equipment qualification, computer and process validation, calibration, and maintenance programs for the manufacture of sterile injectable medications.

· Knowledge and experience in translating FDA and European Medicines Agency (EMA) requirements and guidance into operational success, including but not limited to Annex 1 requirements for sterile injectable medications, 21CFR Part 11, Electronic Records and Signatures, and data integrity are required.

· Technical expertise in sterile pharmaceutical isolator technology, combination products, and medical devices is highly desirable.

· Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.

· Quality management experience across the product development and commercialization lifecycle, including change management and associated implementation strategies.

· Participation and leading activities to support regulatory agency inspections (FDA/EMA) are required.

· Excellent interpersonal and written communication skills and experience using various software/electronic applications are required.

· Ability to synthesize data and provide compliant and pragmatic recommendations to stakeholders.

· Ability to collaborate and manage conflict in a fast-paced environment.

· Self-motivated, flexible, and able to work in a small, start-up, and dynamic environment.

· Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.

**Physical Demands and Work Environment:**

The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee is frequently required to use hands or fingers to handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. The company is an Equal Opportunity Employer, a drug-free workplace, and complies with ADA regulations as applicable

Maintenance Technician, Process Equipment (# 318, # 605)

**About Civica:**

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

*Who suffers most? Patients.*

**Civica** is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica’s plans and progress at [www.civicarx.org](<http://www.civicarx.org/>)

**Position Summary**

The Maintenance Technician, Process Equipment is responsible for driving compliant results in a GMP pharmaceutical manufacturing environment by directly supporting a wide range of service disciplines covering pharmaceutical process equipment such as, but not limited to: fill lines, isolators, parts washers, autoclaves, container closure processing equipment, formulation vessels, labeling equipment, and various lab equipment utilized in the production environments. The Maintenance Technician, Process Equipment, operates in a highly technical environment that requires experience specifically in maintaining safe and reliable production activities. The Maintenance Technician, Process Equipment, applies critical thinking and considers all business-impact factors before taking job-related actions that could lead to unintended consequences, such as unsafe events, equipment failure, and other risks. The Maintenance Technician, Process Equipment, should be able to apply independent judgment and perform in a small-company environment where rapid changes occur. The ideal candidate will have a consistent track record of achieving results in a fast-paced, sterile manufacturing environment and maintaining a positive mindset, driving a positive team culture.

These positions follow a 2-2-3, 12-hour day schedule: 6:00 PM-6:30 AM - 2 days on, 2 days off, 3 days on, 2 days off, 2 days on, 3 days off.

**Essential Duties and Responsibilities**

- Support the day-to-day production activities in the production area. First line of response in case of production equipment malfunction.
- Provide technical expertise and support to production teams, addressing issues and challenges as they arise while working closely with Engineering and other support teams.
- Partner with engineering, calibration, and spare parts teams to ensure proper inventory of key spare parts.
- Partner with engineering in the development and/or revision as required, of preventive maintenance (PM) instructions of production equipment.
- Support the coordination and execution of calibrations and preventative maintenance activities.
- Troubleshoots equipment as necessary, working with equipment owners, engineers, and equipment vendors as needed to reach problem resolutions.
- Proactively work with supports teams Ein developing solutions for equipment issues.
- Completes required paperwork and documentation, work orders and GMP documents in a clear, accurate and in a timely manner.
- Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments (internal and external).
- Collaborate with Manufacturing, Operations, Environmental Health and Safety, and other cross-functional teams to meet production needs.
- Support the onboarding and technical training of Manufacturing staff on process equipment, including high-speed fill lines with integrated Isolators, Terminal Sterilizers, ATEC commodities processing, Parts Washers, Autoclaves, Single-Use Technology, and formulation vessels.
- Assist R&D and MSAT on new product introduction and technology transfer activities.
- Assist in the revision and management of manufacturing documents such as Batch Records and SOPs.
- Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions to minimize impact on operations.
- Periodically on call to monitor and respond to manufacturing equipment repairs and issues.
- Other duties as assigned.

**Basic Qualifications (Knowledge, skills, and abilities)**

- High school diploma with 4 years of experience in executing maintenance to manufacturing equipment, or an associate’s degree or higher in Pharmaceutical Sciences, Engineering, or a related field is preferred.
- Experience with sterile fill-finish manufacturing.
- Knowledge of GMP, regulatory requirements, and industry best practices.
- Ability to work autonomously and within established guidelines, procedures, and practices.
- Experience in a continuous process improvement environment, including change management.
- Experience in using Computerized Maintenance Management Systems.
- Strong communication and collaboration skills, committed to meeting high-quality standards.

**Preferred Qualifications**

- Knowledge of high-speed aseptic filling and isolator barrier system technology.
- Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
- Proficiency in Microsoft Office Suite.

**Physical Demands and Work Environment**

The physical demands described here are those an employee must meet to successfully perform the essential functions of this position. Reasonable accommodation may be provided to enable individuals with disabilities to perform the functions. While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee must frequently use their hands or fingers to handle, feel, or control objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.

The company is an equal opportunity employer, a drug-free workplace, and complies with applicable ADA regulations.

Amgen

Senior Manager Corporate Quality Compliance

Join Amgens Mission of Serving Patients

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

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

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

**Global Quality Compliance, Senior Manager**

**What you will do**

Lets do this. Lets change the world.

Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities:

- Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers to assess compliance with all applicable regulations and to identify top compliance risks.
- Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable).
- Supports preparation of the annual audit plans, as assigned
- Assesses state of compliance with appropriate regulations and participation in the assessment of action plans to correct deficiencies.
- Provides technical and organizational leadership toward resolving site and multi-site compliance issues.
- Alertsexecutivemanagementofsignificantquality,andcompliancerisks.
- Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable
- Provides support for domestic and international Regulatory Authority Inspections whennecessary.
- Serves as senior Global Quality Compliance representative on cross-functional teams (e.g., QMS, GPO, ALF, and special task forces) and interacts with other departments in order to achieve goals.
- Interactswithotherfunctional area leadstoensurethatAmgenStandards, strategies,anddirectionare alignedwithexistingregulationsandregulatoryexpectations.
- Provides support for audit and inspection metrics, as necessary.
- SupportsContinualImprovementinitiatives,programs,andprojects.
- Owns or performs QA approval for DQMS Quality Event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required).

**Additional Requirements:**

- Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity
- Certified Quality Auditor (CQA) or equivalent
- Travel: Domestic and International Approximately 50%

**What we expect of you**

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

**Basic Qualifications:**

- Doctorate degree and 2 years of auditor experience OR
- Masters degree and 6 years of auditor experience OR
- Bachelors degree and 8 years of auditor experience OR
- Associates degree and 10 years of auditor experience OR
- High school diploma / GED and 12 years of auditor experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years 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:**

- Auditing experience in internal audit, affiliate, CMO, Contract laboratory, Transportation/Logistic/Distribution/ warehouse services,
- 50 % international travel requirement
- Knowledge of international regulations and standards
- Auditing certification preferred
- Detail oriented
- Organizational and multi task skills

**What you can expect of us**

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

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

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

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

**Apply now**

**for a career that defies imagination**

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

**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.

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.

District of Columbia

Sr. Maintenance Technician

**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. Maintenance Technician - Days**

**What you will do**

Lets do this. Lets change the world. In this vital role you will be responsible for operating utility systems and performing maintenance activities throughout the ARI site. The position is on a rotating 12 hour day shift (7AM to 7PM, day of week varies per shift schedule).

**Key Accountabilities**

- Maintenance activities are performed safely
- Maintenance activities are completed right the first time
- Maintenance activities are accomplished in timely manner
- Maintenance activities are completed per applicable procedures
- Issues and opportunities that are observed are reported in a timely manner

**Measurement**

- No lost time injuries or near miss incidents
- Minimal rework for maintenance activities
- Labor hours expended are appropriate for job
- All activities are completed per procedure
- All observed issues are reported in a timely manner

**What we expect of you**

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

**Basic Qualifications:**

- High school diploma / GED and 2 years of Maintenance work or Military experience OR
- Associates degree and 6 months of Maintenance work or Military experience

**Preferred Qualifications:**

- 5+ years of combined education, training, and experience in utility/HVAC/refrigeration systems and maintenance including clean/sanitary utility systems.
- 3+ years knowledge of pneumatic, mechanical and hydraulic systems and ability to effectively perform associated maintenance activities.
- Knowledge and experience in Rigging, Welding, Plumbing, Pipefitting.
- Knowledge and experience working in a highly regulated function - cGMP.
- Experience executing and documenting maintenance work orders in the Maximo computerized maintenance management system.
- Experience with building automation systems as they relate to utility/HVAC systems.
- Ability to interpret P&ID's.
- Strong computer skills
- Ability to provide guidance and technical advice to others
- Ability to work with minimum direction.
- Ability to effectively communicate issues and status of tasks in a timely manner.
- Ability to interact constructively with peers/teams.

**What you can expect of us**

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

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

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

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

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

**careers.amgen.com**

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

**Application deadline**

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

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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.

Rhode Island

GCP Auditor - Global R&D Audit

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-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.

**GCP Auditor - Global R&D Audit**

**What you will do**

Lets do this. Lets change the world. You would be joining Amgens R&D Quality Audit Team of expert, professional and widely experienced individuals working with a global remit across Amgens portfolio in all stages of development and post marketing. The R&D Quality audit team is part of Amgen's R&D Quality Group.

In this vital role within R&D Quality you will be planning and participating in global audits of Amgens clinical trials activities. You may also support regulatory inspections of clinical sites and Amgen facilities. The key responsibilities include:

- Plan, conduct and report routine and direct GCP compliance audits internationally.
- Serve as a lead auditor for complex GCP audits
- Identify and communicate compliance risks to R&D Quality management
- Host and/or play a role in regulatory authority inspections
- Contribute to or lead R&D Quality process improvement initiatives
- Author and contribute to the development of R&D Quality cross functional controlled documents

The role can entail up to 40% travel to international destinations

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

**Basic Qualifications:**

- Doctorate degree OR
- Masters degree and 2 years of scientific discipline, medical sciences or pharmacy experience OR
- Bachelors degree and 4 years of scientific discipline, medical sciences or pharmacy experience OR
- Associates degree and 8 years of scientific discipline, medical sciences or pharmacy experience OR
- High school diploma / GED and 10 years of scientific discipline, medical sciences or pharmacy experience

**Preferred Qualifications:**

- Postgraduate qualification
- Participation in process improvement initiatives.
- Extensive experience conducting international auditing in GCP or as a regulatory authority inspector
- Experience of data mining, manipulation and data analytics would be advantageous
- Excellent written and verbal communication skills

**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.

Senior Maintenance Technician Utilities Day Shift

**HOW MIGHT YOU DEFY IMAGINATION?**

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch 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 Maintenance Technician Utilities Day Shift**

**Live**

**What you will do**

Lets do this! Lets change the world! In this valuable role you will provide technical expertise and guidance supporting the start-up of the plant utilities and daily operations. **This position is Monday through Friday, 7AM to3:30PM.**

- Perform intermediate installation, troubleshooting, maintenance, repair, testing and documentation/logs of process and utility equipment.

- Perform operations, maintenance and repair activities on utility equipment and systems providing utilities serving Manufacturing, Lab, and various operations across the ANC site:

- Specific plant systems include: steam, chilled water, compressed air, cooling tower water, and heating hot water.

- Specific Manufacturing and Lab utility systems include: clean steam, water for injection (WFI), process cooling water, process air, process gases, process waste, HVAC systems, walk-in cold rooms and freezers, and other environmental control units (chambers).

- Maintenance activities include: inspections, testing, minor/major equipment overhauls, pump rebuild/replacements, valve rebuild/replacements, HVAC troubleshooting/repair, piping modification/repair, etc.

- Additional responsibilities include partnering with maintenance service providers and equipment vendors.

- Complete quality and safety documentation and completion of work in a safe, compliant, and timely manner according to planning and predefined schedules with minimal impact to production while aligning with GMPs, SOPs and Amgen policies and regulations.

- Work in a highly productive and efficient manner to maximize the quantity of activities completed with focus on maintenance excellence.

- Ensure work is appropriately communicated to system operators and key stakeholders.

- Ensure work order documentation is completed accurately.

- Review maintenance reports, forms, plans and records.

- Identify waste, work-flow interrupters, and other opportunities for improvement, recommend solutions, and assist with implementation.

- Identify opportunities to learn new skills and actively participate in development that will improve overall team performance.

- Represent the Utilities Maintenance team in discussions and meetings with management and peers.

- Provide facility and manufacturing support as needed with on-call rotation - this may be outside of normal working hours including nights, weekends and holidays.

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The Maintenance teammate we seek is a dynamic candidate with these qualifications.

**Basic Qualifications:**

- High School Diploma / GED and 2 years of Utility Operations or Maintenance experience OR
- Associates Degree and 6 months of Utility Operations or Maintenance experience OR

**Preferred Qualifications:**

- 5+ years knowledge of utility operations and mechanical maintenance with an emphasis on plant utility equipment and systems (chillers, boilers, cooling towers, air compressors, etc.) and ability to effectively perform associated maintenance activities.

- 3+ years knowledge of pneumatic, mechanical, and hydraulic systems and ability to effectively perform associated maintenance activities.

- Knowledge and experience within a cGMP or other highly regulated environment.

- Experience executing and documenting maintenance work orders in a computerized maintenance management system.

- Ability to interpret P&ID's.

- Ability to work with minimum direction.

- Ability to effectively communicate issues and status of tasks in a timely manner.

- Ability to interact constructively with peers/teams.

**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.

This position will be paid on an hourly basis. The annualized base pay range for this opportunity in the U.S. is $67,204 - $82,445.

In addition to the base salary, 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 now**

**for a career that defies imagination**

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

**careers.amgen.com**

\#AmgenNorthCarolina

North Carolina

Senior Manager Corporate Audit

**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.

**Senior Manager Corporate Audit**

**What you will do**

Lets do this. Lets change the world. In this vital role you will

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

**Basic Qualifications**

- Bachelors degree with an emphasis i
- Doctorate degree and 2 years in Accounting, Finance, Business Administration or Compliance
  OR
  Masters degree and 4 years in Accounting, Finance, Business Administration or Compliance
  OR
  Bachelors degree and 6 years in Accounting, Finance, Business Administration or Compliance
  OR
  Associates degree and 10 years in Accounting, Finance, Business Administration or Compliance
  OR
  High school diploma / GED and 12 years in Accounting, Finance, Business Administration or Compliance

**Preferred Qualifications**

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

Equipment Maintenance Technician (12 hour rotation, Night Shift)

**Join Amgens Mission of Serving Patients**

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

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

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

Associate Tech Engineering I

**Live**

**What you will do**

Lets do this. Lets change the world. In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, repairs, and modifications. You will evaluate and determine if process equipment maintenance, and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.

**Responsibilities:**

- Take part in the coordination of tech support on engineering, regulatory, compliance, quality, microbial/environmental, technical cleaning, validation, and mechanical, electrical and process automation issues.
- Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
- Complete maintenance activities or operate and monitor plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and Amgen policies.
- Investigate issues or problems through the mentorship of experienced staff.
- Assist with maintaining an up-to-date working spare parts inventory system for the equipment/systems.
- Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
- Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and P&IDs.
- Support Operations in non-standard shifts that includes weekends and/or holidays as determined by business.
- Ability to work night shift

**Win**

**What we expect of you**

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

**Basic Qualifications:**

**Bachelors degree**

OR

Associates degree and 4 years of Technical Engineering experience

**Or**

High school diploma / GED and 6 years of Technical Engineering experience

**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)
- Ability to read and interpret electrical schematics and use a digital multimeter
- 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 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.

**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.

Ohio

Utilities Maintenance Technician - HVAC

**HOW MIGHT YOU DEFY IMAGINATION?**

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch 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.

**Utilities Maintenance Technician - HVAC**

**Live**

**What you will do**

Lets do this. Lets change the world. In this valuable role you willprovide Heating, Ventilation and Air Conditioning (HVAC)technicalexpertiseand guidance supporting the start-up of the plant utilities and daily operations.

- Performing intermediate installation, troubleshooting, maintenance, repair, testing and documentation/logs ofHVAC and utilityequipmentincluding HVAC systems, cold rooms and other environmental control units.

- Performing operations, maintenance and repair activities on utility equipment and systems providing utilities serving Manufacturing, Lab, and various operations across the ANC site:

- Specific Manufacturing and Lab HVAC systems include:Air Handling and Exhaust Fan units, Bio-Safety cabinets, air directional flow hoods, HEPA filters, walk-in cold rooms and freezers (refrigeration systems) and other environmental control units (chambers).

- Maintenance activities include inspections, testing, minor/major equipment overhauls, pump rebuild/replacements, valve rebuild/replacements, HVAC troubleshooting/repair, HEPA filter certification, Piping modification/repair, etc.

- Additional responsibilities include overseeing maintenance service providers and equipment vendors.

- Completing quality and safety documentation and completing the work in a safe, compliant, and timely manner according to planning and predefined schedules with minimal impact to production while aligning with GMPs, SOPs and Amgen policies and regulations.

- Work in a highly productive and efficient manner to maximize the quantity of activities completedwith focus on maintenance excellence.

- Ensure work is appropriately communicated to system operators and key stakeholders.

- Ensure work order documentation is completed accurately.

- Reviewing and technically approving maintenance reports, forms, plans and records.

- Identify waste, work-flow interrupters, and other opportunities for improvement, recommend solutions, and assist with implementation.

- Identify opportunities to learn new skills and actively participate in development that will improve overall team performance.

- Represent the Utilities Maintenance team in discussions and meetings with management, peers and other site functions.

- Provide facility and manufacturing support as needed with on-call rotation - this may be outside of normal working hours including nights, weekends and holidays.

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The Maintenance teammate we seek is a dynamic candidate with these qualifications.

**Basic Qualifications:**

High school diploma / GED and 1 years of HVAC Operations or Maintenance experience

**Preferred Qualifications:**

We are all different, yet we all use our unique contributions to serve patients. The Maintenance teammate we seek is a dynamic candidate with these qualifications.

- 4+ years of combined education, training, and experience in HVAC utility operations and mechanical maintenance with an emphasis on facility and plant HVACequipment and systems.

- 2+ years knowledge of HVAC operations and systems and ability to effectively perform associated maintenance activities.

- Demonstrated knowledge of HEPA testing and certification

- EPA 608 Certification

- Demonstrated knowledge of refrigeration systems, components, and controls.

- Demonstrated refrigeration and DX cooling experience

- Working knowledge of local and national building code requirements.

- Knowledge and experience working in a highly regulated function cGMP.

- Experience executing and documenting maintenance work orders in a computerized maintenance management system.

- Ability to interpret mechanical drawings.

- Ability to work with minimum direction.

- Ability to effectively communicate issues and status of tasks in a timely manner.

- Ability to interact constructively with peers/teams.

**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.

The annual base salary range for this opportunity in the U.S. is provided below.

In addition to the base salary, 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 now**

**for a career that defies imagination**

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

**careers.amgen.com**

\#AmgenNorthCarolina

Manager Maintenance Utilities - Night Shift

**HOW MIGHT YOU DEFY IMAGINATION?**

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Amgen, one of the worlds leading biotechnology companies is investing $550 million to build a new multi-product drug substance biomanufacturing facility in Holly Springs, North Carolina, a biomanufacturing hub known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel-fed batch and single use technology. This combination of capabilities is an approach that Amgen calls FleX Batch manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability, aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgens plan to be carbon neutral by 2027.

**Manager Maintenance Utilities**  **- Night Shift**

**Live!**

**What you will do**

Lets do this. Lets change the world. In this vital role you will provide technical and administrative leadership to a large and diverse group of craft-oriented personnel, including utility operators, electricians, and HVAC maintenance technicians.

**This position has a base schedule of 3pm 11pm, Monday through Friday.**

**During construction phase:**

- Support the start-up of all site utility systems and transfer of ownership to the F&E utilities team.
- Develop and implement a long-term strategy for leading continuous plant and clean utility operations and maintenance of installed systems and equipment including system setups in Maximo etc.
- Support the development and implementation of goals and objectives and associated budgets for all utility services and equipment including but not limited to site utility accounts (electric, natural gas, water/sewage, etc.) and maintenance programs.
- Ensure utility operations and maintenance programs are aligned with cGMP and safety requirements, local/ global regulations, and Amgen Maintenance excellence standards.
- Institute supporting organization and business structures, including innovation and talent development.
- Ensure that procedures are in place for cGMP and daily activities and are followed by area personnel and contractors.
- Ensure safety of all personnel during plant construction and start-up operations and maintenance activities across multiple shifts providing 24/7 plant and utility coverage.

**Post-Construction completion and continued operations:**

- Responsible for leading the Amgen NC F&E utility staff and Service Providers supporting continuous clean and plant utility operations including electrical and HVAC systems at the site.
- Provide support as required, including outside of normal working hours to maintain continuous and compliant (safety, quality, etc.) utility operations at the site.
- Management and monitoring of a robust utility system maintenance program consisting of preventive, predictive, and corrective maintenance activities to improve personnel safety, equipment reliability, overall equipment efficiency, and product quality.
- Ensure that all staff are trained and follow all safety and GMP standards and procedures.
- Improve staff productivity and the efficient use of available resources across facilities.
- Analysis and accurate review of engineering / construction / maintenance cost forecasts against scope.
- Oversight and execution of sophisticated facilities/utilities/maintenance related initiatives and small projects. Provide expertise and resources for capital project execution.
- Work cross-functionally with individuals, partners, clients, and others in Engineering, Environmental Health & Safety, Quality, Supply Chain and Manufacturing networks.
- Maintain and improve plant capability and equipment reliability in partnership with engineering leadership and technical staff.
- Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects and lead or support implementation.
- Maintain and develop key performance indicators of maintenance performance, lead, assess, develop staff and ensure that all targets and achievements are completed on time and on budget.
- Support network-wide improvement in plant maintenance and operation.
- Provide leadership and guidance to organizational resources to accomplish activities and objectives.
- Build a culture that cultivates and rewards creativity and innovation.

**Win!**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The utilities maintenance professional we seek is a leader with these qualifications.

**Basic Qualifications:**

- High school diploma / GED and 10 years of Manufacturing Equipment Maintenance experience OR
- Associates degree and 8 years of Manufacturing Equipment Maintenance experience OR
- Bachelors degree and 4 years of Manufacturing Equipment Maintenance experience OR
- Masters degree and 2 years of Manufacturing Equipment Maintenance experience OR
- Doctorate degree

**AND** 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:**

- 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- 4+ years experience in engineering or utility operations within biotechnology and/or pharmaceutical or other regulatory environments, or Military experience
- 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 apply analytical skills to evaluate and interpret complex problems using multiple sources of information
- Ability to lead multiple tasks and effectively set priorities
- Demonstrated ability in goal setting and driving continuous improvement through setting and monitoring of key metrics
- Extensive knowledge of electro-mechanical, fluid, and gas equipment and systems
- Solid understanding of maintenance management, utilities operations programs, and Computerized Maintenance Management Systems
- Demonstrated skill in analyzing and improving facilities related quality systems

**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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

**Apply now for a career that defies imagination**

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

**careers.amgen.com**

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 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.

Director, Global Diagnostics Strategy Lead

**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.

**Director, Global Diagnostics Strategy Lead**

**What you will do**

In this vital role, the Director, Global Diagnostic Strategy Lead (DxSL) will lead the creation, alignment, and execution of comprehensive global diagnostic strategies for assigned molecules and programs within a disease area or therapeutic area. The DxSL serves as the primary diagnostic strategy point of contact for program teams and governance forums, helping ensure that diagnostic development plans enable clinical development, regulatory approval, launch, commercialization, and lifecycle management of precision therapeutics.

The Diagnostics (Dx) Group is responsible for the successful transition of biomarker assays into marketed diagnostics that support therapeutic development strategy, regulatory approval, access, and commercialization.

**You will:**

- Develop and lead integrated, end-to-end diagnostic strategies from early diagnostic need assessment through launch and lifecycle management.
- Partner with Product Teams, program leadership and other decision-making forums, to align therapeutic and diagnostic development objectives.
- Evaluate and propose diagnostic strategic options, including assay and platform approaches, partner strategy, regulatory and commercial pathways, trade-offs, opportunities, costs, timelines, and risks.
- Lead and oversee Dx Development Teams (DxDTs) to ensure tactical execution of the diagnostic development plan and alignment between Rx and Dx development programs.
- Influence decision-making in a matrixed environment by communicating balanced, unbiased assessments of diagnostic opportunities and risks.
- Represent the Dx function with internal stakeholders and external diagnostic development partners.
- Manage, coach, and develop a small team of Dx technical leads, as applicable, while delivering through cross-functional leadership and influence.

**Key Responsibilities**

**Diagnostic strategy and portfolio leadership**

- Assess the need for diagnostic development for each assigned molecule or program within the disease area or therapeutic area portfolio.
- Work with cross-functional Dx subject matter experts and program functional leads to build comprehensive, global, long-term diagnostic strategies that support program objectives.
- Document and communicate diagnostic strategy through appropriate templates, decision materials, and executive-ready slide decks.
- Provide strategic input to program teams and governance forums to enable informed decisions on diagnostic development options.

**Execution through Dx Development Teams**

- Oversee DxDTs to ensure delivery of diagnostic development plans, milestones, timelines, risks, mitigations, and interdependencies.
- Partner with Project Management to track risks, mitigations, milestones, timelines, resources, and financials across diagnostic development activities.
- Ensure diagnostic strategies and plans are integrated with therapeutic development plans and clinical trial execution needs.
- Operate within Amgen governance, policy, and decision-making frameworks, including DAI where applicable.

**External partner strategy and business planning**

- Work across Amgen functions to identify, evaluate, and select diagnostic development partners as needed.
- Oversee partner-selection activities related to diagnostic development, including workplan development and alignment on scope, roles, and deliverables.
- Lead collaboration with external diagnostic partners to integrate diagnostic development, approval, and launch strategies.

**Global launch, commercialization, and lifecycle management**

- Ensure diagnostic strategies incorporate global clinical, regulatory, commercial, access, and regional execution requirements.
- Partner with global and regional commercial teams to align on commercial diagnostic strategy, including regional or country gap assessments.
- Lead lifecycle management planning for diagnostic platforms or assays to support program objectives after initial approval and launch.
- Support diagnostic market landscape assessments and business case development for key strategic choices.

**Matrix leadership and stakeholder engagement**

- Communicate effectively with Amgen leadership, therapeutic product teams, cross-functional collaborators, and external partners.
- Lead with courage and influence without direct authority across a complex matrix environment.
- Proactively provide balanced and thoughtful input to product teams and other work package teams.
- Actively seek and incorporate input from Dx Regulatory, Drug Regulatory, Clinical, Medical, Commercial, Value and Access, Business Development, Alliance Management, and other stakeholders.

**Core Deliverables**

- Comprehensive diagnostic development strategies for assigned drug development programs and portfolio priorities.
- Documented Dx strategy materials, including strategy templates, decision documents, and slide decks for cross-functional alignment and governance discussions.
- Aligned Rx/Dx development plans with clear milestones, risks, mitigations, timelines, and accountabilities.
- Diagnostic partner selection recommendations and workplans, where partner support is needed.
- Global and regional diagnostic launch, commercialization, and lifecycle management plans.
- Dx representation and strategic input at Product Team, EGT, CBDT, DxLT and other relevant forums.

**Basic Qualifications**

- Doctorate degree and 4 years of pharmaceutical, biotechnology, diagnostics, clinical development, or related experience; OR
- Master's degree and 8 years of pharmaceutical, biotechnology, diagnostics, clinical development, or related experience; OR
- Bachelor's degree and 10 years of pharmaceutical, biotechnology, diagnostics, clinical development, or related experience; AND

**Preferred Qualifications**

- Direct experience developing and implementing diagnostic, companion diagnostic, or precision medicine strategies within a pharmaceutical, biotechnology, or diagnostics setting.
- Advanced degree in biomedical sciences, medicine, diagnostics, molecular biology, pathology, genomics, oncology, or related discipline (Ph.D., M.D., Pharm.D., or equivalent).
- Strong scientific acumen paired with a strategic mindset and the ability to translate biomarker and diagnostic insights into development and commercialization strategies.
- Knowledge of the clinical, regulatory, commercial, and access considerations that shape global diagnostic development and launch plans.
- Documented experience with oncology precision medicine, in vitro diagnostics (IVD), companion diagnostics (CDx), biomarker assay development, or diagnostic platform lifecycle management.
- Experience evaluating diagnostic technologies, development options, market landscapes, and business cases, including trade-offs related to cost, time, risk, opportunity, and global execution.
- Demonstrated ability to lead cross-functional teams, influence without authority, and gain alignment across senior stakeholders in a matrix environment.
- Experience working with external diagnostic partners, business development, alliance management, and/or partner governance structures.
- Familiarity with global regulatory submission requirements and diagnostic evidence expectations across major markets.
- Experience with clinical trial design, biomarker-driven enrollment or testing strategies, and integration of diagnostic requirements into therapeutic development plans.
- Excellent executive-level communication, presentation, facilitation, and decision-framing skills.
- Strong project leadership skills, including resource planning, timeline management, risk identification, risk mitigation, and financial awareness.
- Learning agility, organizational savvy, self-awareness, adaptability in changing environments, and an organized work style.

**What you can expect of us**

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

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

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

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

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

**careers.amgen.com**

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

**External/Internal postings:**

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.

**Internal only posting (or Pre-ID candidate):**

Amgen anticipates accepting applications until 1-2 weeks after the job posting; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

**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.

California

Quality Control Specialist, Microbiology

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-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.

**Quality Control Specialist, Microbiology**

**What you will do**

Lets do this. Lets change the world. In this vital role, you will provide technical and operational leadership for the QC Microbiology and Environmental Monitoring laboratories, leading microbial identification activities, environmental monitoring investigations, and laboratory operations in a highly dynamic, team-oriented environment.

In this role, you will be responsible for:

- Lead microbial identification activities, organism assessments, and support routine and non-routine microbiological testing.
- Provide leadership for microbiology laboratory operations, coordinate daily priorities, supervise laboratory staff, and support weekend laboratory operations.
- Own and lead complex microbiological investigations, deviations, environmental monitoring excursions, and contamination events, including root cause analysis, risk assessments, and product impact assessments.
- Provide technical expertise for environmental monitoring, bioburden control, microbial identification, contamination control strategies, and laboratory controls.
- Author and drive CAPAs, microbial risk assessments, and change controls to ensure compliant resolution of quality events.
- Coordinate contract laboratory activities, including testing support, data review, investigation collaboration, and approval of associated documentation.
- Generate and maintain complete, accurate, and inspection-ready documentation using electronic laboratory and quality systems (e.g., LMES, LIMS, CIMS, and Veeva).
- Partner with Quality, Manufacturing, Engineering, and global microbiology teams to support process improvements, operational excellence initiatives, regulatory inspections, and strategic microbiology projects.

**What we expect of you**

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

**Basic Qualifications:**

- High school diploma / GED and 10 years of Quality, Microbiology or Operations experience **OR**
- Associates degree and 8 years of Quality, Microbiology or Operations experience **OR**
- Bachelors degree and 4 years of Quality, Microbiology or Operations experience **OR**
- Masters degree and 2 years of Quality, Microbiology or Operations experience **OR**
- Doctorate degree

**Preferred Qualifications:**

- Microbiology degree and/ormicrobiology laboratory experience associated with microbial identification.
- Demonstrated leadership experience, including coaching and developing staff, prioritizing laboratory workloads, and supporting routine and non-routine microbiological testing.
- Understanding of manufacturing processes associated with contamination control.
- Experience supporting regulatory inspections and audit readiness activities.
- Advanced technical writer who can articulate complex events into concise, clear, and contemporaneous documentation that is inspection ready.
- Professional work experience in a fast-paced, flexible GMP laboratory.
- Ability to generate, investigate, triage and close deviations and analytical test result assessments in Veeva.
- Ability to generate and document validation protocols and reports.
- Experience performing aliquoting of samples aseptically.
- Operation, maintenance experience with laboratory equipment.
- Ability to generate and revise methods and SOPs within CDOCs.
- Demonstrated proficiency with electronic systems capturing consumables, testing procedures, results, and investigations (SAP, LIMS, LMES, CIMS, Veeva, etc.).
- Demonstrated understanding and use of Maximo (Work Order System)
- Ability to manage and lead Operational Excellence initiatives including 5S and Standard Work associated with the testing labs.
- Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively.
- Demonstrated ability to be flexible and adaptable to support business needs.

**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.

Senior Maintenance Technician Utilities (Waste Water Treatment) Day Shift

**HOW MIGHT YOU DEFY IMAGINATION?**

Youveworked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills,experienceand passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over10 million patientsworldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

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 Maintenance Technician Utilities (Waste Water Treatment) Day Shift**

**Live**

**What you will do**

Letsdo this!Letschange the world! In this valuableroleyou will provide technicalexpertiseand guidance supporting the start-up ofthe plantutilities and daily operations. This position is on a rotatingdayshift (2-2-3schedule,7AMto7PM).

The Senior Wastewater Treatment Operator/Mechanicis responsible forthe operation, monitoring, maintenance, troubleshooting, and optimization of industrial wastewater treatment systems to ensure compliance with all local, state, and federal discharge permit requirements. This position serves as a technical lead for wastewater treatment operations, laboratory testing, process control, preventive maintenance, equipment repairs, and operator training.

The Senior Operator/Mechanic works independently tomaintaintreatment system performance, monitor permit compliance parameters, and perform mechanical and electrical maintenance on wastewater treatment equipment including pumps, mixers, chemical feed systems, Dissolved Air Flotation (DAF) systems, instrumentation, controls, and associated utilities.

- Operate andmonitorindustrial wastewater treatment processes including equalization, pH adjustment, chemical treatment, dissolved air flotation (DAF), sludge handling, and discharge systems.

- Monitor wastewater flow, pH, Total Suspended Solids (TSS), Total Dissolved Solids (TDS), Biological Oxygen Demand (BOD), Total Nitrogen (TN), Ammonia Nitrogen (NH3-N), Total Phosphorus (TP), Chlorides, and other permit-regulated parameters.

- Conduct routine inspections of treatment systems, tanks, pumps, valves, piping, instrumentation, and process equipment.

- Evaluate treatment performance and make operational adjustments tomaintaincompliance with discharge permits.

- Monitor SCADA, PLC, HMI, and automated control systems to ensure proper operation.

- Respond to process alarms and emergency situations to preventpermitviolations and operational disruptions.

- Maintainaccurateoperational logs, inspection reports, and compliance documentation.

**Safety and Environmental Compliance**

- Follow all environmental, health, and safety regulations and company policies.

- Utilizeappropriate personalprotective equipment (PPE).

- Participate in confined space entry, lockout/tagout, chemical handling, and emergency response activities.

- Maintain compliance with wastewater discharge permits and environmental regulations.

**Mechanical Maintenance**

- Performoperation,troubleshooting, maintenance, repair,testingand documentation/logs ofsite wastewater treatment system.

- Supportoperations, maintenance and repair activities on utility equipment and systems providing utilities serving Manufacturing, Lab, and various operations across the ANC site:

- Specific plant systemsinclude:steam, chilled water, compressed air, cooling tower water, and heating hot water.

- Specific Manufacturing and Lab utility systemsinclude:clean steam, water for injection (WFI), process cooling water, process air, process gases, process waste, HVAC systems, walk-in cold rooms and freezers, and other environmental control units (chambers).

- Maintenance activitiesinclude:inspections, testing, minor/major equipment overhauls, pump rebuild/replacements, valve rebuild/replacements, HVAC troubleshooting/repair, piping modification/repair, etc.

- Additionalresponsibilities include partnering with maintenance service providers and equipment vendors.

- Complete quality and safety documentation and completion of work in a safe, compliant, andtimelymanner according to planning and predefined schedules with minimal impacttoproduction while aligning with GMPs, SOPs and Amgen policies and regulations.

- Ensure work order documentation is completed accurately.

- Identifywaste, work-flow interrupters, and other opportunities for improvement, recommend solutions, andassistwith implementation.

- Identifyopportunities to learn new skills and activelyparticipatein development that will improve overall team performance.

- Represent the Utilities Maintenance team in discussions and meetings with management and peers.

- Provide facility and manufacturing support as needed with on-call rotation - this may be outside of normal working hours including nights,weekendsand holidays.

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The Maintenance teammate weseekis a dynamic candidate with these qualifications.

**Basic Qualifications:**

- High School Diploma / GED and6years ofWater TreatmentOperations or Maintenance experience

Or

- 2 years in a Technical School setting with hands-on experience inWaterTreatmentOperations or Maintenance experience

**Preferred Qualifications:**

- 5+yearsknowledge ofwastewater treatmentoperations and mechanical maintenance and ability to effectively perform associated maintenance activities.

- 3+yearsknowledge of pneumatic, mechanical, and hydraulic systems and ability to effectively perform associated maintenance activities.

- Knowledge and experience within a cGMP or other highly regulated environment.

- Experience executing and documenting maintenance work orders in a computerized maintenance management system.

- Ability to interpret P&ID's.

- Ability to work with minimum direction.

- Ability to effectively communicate issues and status of tasksin a timely manner.

- Ability to interact constructively with peers/teams.

**Thrive**

**What you can expect of us**

In addition to the base salary, Amgen offers a Total Rewards Plancomprisinghealth 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 now**

**for 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.

Job Description

**Join Amgens Mission of Serving Patients**

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

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

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

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch 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 Maintenance Technician Utilities Day Shift**

**What you will do**

Lets do this. Lets change the world. In this valuable role you will provide technical expertise and guidance supporting the start-up of the plant utilities and daily operations. This position is on a rotating day shift (2-2-3 schedule, 7am to 7pm).

- Perform intermediate installation, troubleshooting, maintenance, repair, testing and documentation/logs of process and utility equipment.
- Perform operations, maintenance and repair activities on utility equipment and systems providing utilities serving Manufacturing, Lab, and various operations across the ANC site:
- Specific plant systems include: steam, chilled water, compressed air, cooling tower water, and heating hot water.
- Specific Manufacturing and Lab utility systems include: clean steam, water for injection (WFI), process cooling water, process air, process gases, process waste, HVAC systems, walk-in cold rooms and freezers, and other environmental control units (chambers).
- Maintenance activities include: inspections, testing, minor/major equipment overhauls, pump rebuild/replacements, valve rebuild/replacements, HVAC troubleshooting/repair, piping modification/repair, etc.
- Additional responsibilities include partnering with maintenance service providers and equipment vendors.
- Complete quality and safety documentation and completion of work in a safe, compliant, and timely manner according to planning and predefined schedules with minimal impact to production while aligning with GMPs, SOPs and Amgen policies and regulations.
- Work in a highly productive and efficient manner to maximize the quantity of activities completed with focus on maintenance excellence.
- Ensure work is appropriately communicated to system operators and key stakeholders.
- Ensure work order documentation is completed accurately.
- Review maintenance reports, forms, plans and records.
- Identify waste, work-flow interrupters, and other opportunities for improvement, recommend solutions, and assist with implementation.
- Identify opportunities to learn new skills and actively participate in development that will improve overall team performance.
- Represent the Utilities Maintenance team in discussions and meetings with management and peers.
- Provide facility and manufacturing support as needed with on-call rotation - this may be outside of normal working hours including nights, weekends and holidays.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The Maintenance teammate we seek is a dynamic candidate with these qualifications.

**Basic Qualifications:**

- High School Diploma / GED and 2 years of Utility Operations or Maintenance experience OR
- Associates Degree and 6 months of Utility Operations or Maintenance experience OR

**Preferred Qualifications:**

- 5+ years knowledge of utility operations and mechanical maintenance with an emphasis on plant utility equipment and systems (chillers, boilers, cooling towers, air compressors, etc.) and ability to effectively perform associated maintenance activities.
- 3+ years knowledge of pneumatic, mechanical, and hydraulic systems and ability to effectively perform associated maintenance activities.
- Knowledge and experience within a cGMP or other highly regulated environment.
- Experience executing and documenting maintenance work orders in a computerized maintenance management system.
- Ability to interpret P&ID's.
- Ability to work with minimum direction.
- Ability to effectively communicate issues and status of tasks in a timely manner.
- Ability to interact constructively with peers/teams.

**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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

**careers.amgen.com**

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.

Senior Manager Instrumentation and Maintenance

**Join Amgens Mission of Serving Patients**

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

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

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

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch 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** **Instrumentation and Maintenance**

**What you will do**

Lets do this. Lets change the world. The Senior Manager Instrumentation and Maintenance will join the Facilities & Engineering (F&E) group reporting to the Facilities & Engineering (F&E) Director. In this vital role, you will oversee the Maintenance and Instrumentation team and will provide technical and administrative leadership to a large and diverse group of craft-oriented personnel, including maintenance and instrumentation technicians. You will also provide leadership and guidance to the Maintenance and Instrumentation team supporting 24/7 operations.

**Site design, construction, start-up, and operational readiness:**

- Build and lead a team of Maintenance and Instrumentation professionals and serve as the main point of contact for the Maintenance function.
- Develop and implement long term strategy for technical support for ongoing operations and maintenance 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 maintenance services including but not limited to site maintenance and calibration programs.
- Ensure Preventive Maintenance and Calibration 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:**

- Lead a team of Maintenance and Instrumentation professionals and serve as the main point of contact for the Maintenance and Instrumentation function.
- Manage maintenance related 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.
- Responsible for execution of maintenance and calibration program to support 24/7 reliability of plant operations.
- 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 plant capability and equipment 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 facilities/maintenance 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 Maintenance, 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:**

- High school diploma / GED and 12 years of engineering experience OR
- Associates degree and 10 years of engineering experience OR
- Bachelors degree and 8 years of engineering experience OR
- Masters degree and 6 years of engineering experience OR
- Doctorate degree and 2 years of engineering experience

And

- In addition to meeting at least one of the above requirements, you must have a minimum of 2 years 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:**

- 6+ years experience in engineering or maintenance within the biotechnology and/or pharmaceutical or other regulatory environments, or Military experience
- 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
- Strong knowledge of maintenance management and 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.

**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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

**careers.amgen.com**

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.

GenScript

Intern - Protein Quality Control

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

**Key Responsibilities**

- Responsible for the concentration test, SDS-PAGE, Western blot analysis, HPLC and endotoxin test of protein samples
- Summarizing, analyzing and processing experimental data, analyzing and sorting out unqualified data, conducting experimental operations and writing experimental records
- Responsible for the formulation and update of SOP, summarising and solidifying work experience
- Managing instruments, and being able to carry out maintenance as required
- Complete other tasks assigned by the supervisor

**Key Requirements**

- Diploma/Bachelor’s Degree in Biological Sciences / Life Sciences / Bioengineering / Chemistry or related courses
- Familiar with the experimental operation of SDS-PAGE, Western blot, and other protein detection
- Good troubleshooting skills
- Strong sense of achievement; resilient and able to perform under the pressure
- Team player with good communication skills (verbal and written)
- Available to work 8-hour shifts, 5 days a week, with 2 rest days that may not always fall on weekends

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Other Non-US

QC Specialist

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

**Job Scope:**

- Responsible for coordinating QC and QA work in the team
- Responsible for the completion of key orders and trouble shooting
- Responsible for statistics and analysis of production data, and assist the supervisor to optimize and improve the production process or technology
- Participate in or be responsible for the management of multiple promotion projects and promote the achievement of project objectives
- Responsible for the formulation and update of SOP, summarize and solidify work experience and train up junior employees
- Assist the supervisor to complete quality monitoring and safety inspection, and timely complete problem rectification
- Complete other tasks assigned by the supervisor

**Key Requirements:**

- Bachelor’s degree or above in cell biology, molecular biology, biomedicine and other related majors
- Familiar with the experimental operation of SDS-PAGE, Western blot, LC-MS, HPLC and other protein detection,
- Good trouble shooting and project management skills
- Good communication skills (verbal and written)
- Good collaboration skills

\#GS

\#LI-MF1

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Manager of Quality Assurance

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

The position reports to the Senior Vice President of the Innovation Center and is responsible for the strategic development and operational management of the site’s ISO 9001-certified Quality Management System (QMS). The QA Manager is accountable for ensuring consistent and harmonized execution of quality systems, including facility/utility/equipment qualification, quality systems establishment and maintenance, raw material management, production process support, product release, deviation and CAPA management, change management, and risk management across the Seattle, WA site.

The role will ensure consistent execution of quality systems across the Seattle site covers multiple production lines, QC groups, and R&D teams.

1. Based on corporate policies, develop the QMS strategy and establish quality procedures to support RUO production and R&D activities at the Seattle site.
2. Customer & ISO Audits: Lead and host frequent customer audits and ISO 9001 surveillance audits. Act as the primary face of Quality for the site, effectively demonstrating the robustness of our QMS to external partners
3. Supplier Qualification: Manage the site's supplier qualification lifecycle. Evaluate, approve, and continuously monitor external providers of raw materials and services through questionnaires, audits, and performance tracking to ensure ISO 9001 compliance.
4. Customer Quality Agreements: Negotiate and manage Customer Quality Agreements (CQAs) and efficiently handle customer supplier questionnaires, ensuring alignment between client expectations and our RUO manufacturing standards.
5. R&D and Tech Transfer: Partner with the R&D teams to support new technology development, ensuring seamless tech transfer. Review and approve R&D SOPs, reports, and risk assessments promptly to maintain the agility required for RUO environments without creating bureaucratic bottlenecks.
6. Provide cross-site quality leadership for QMS lifecycle maintenance, raw material management, final product release, supply chain, automation, manufacturing, validation, and facility engineering across all 3 production lines.
7. Apply Quality by Design principles to define robust, integrated control strategies for the oligonucleotide, synthetic gene, mRNA, and formulation manufacturing processes.
8. Oversee and manage the execution of quality systems during daily production activities to ensure the delivery of high-quality RUO molecular biology products.
9. Present updates to project or upper management teams on progress and enforcement of quality improvement and manufacturing support activities.

**Qualifications:**

1. Master’s degree in a life sciences-related field (or equivalent) with 5+ years of QA/QC experience in a biotech production environment, including substantial management responsibility.
2. Experience with molecular biology product manufacturing (oligonucleotides, synthetic gene, mRNA) or formulation services is highly desirable.
3. Completed Lead Auditor training or possesses deep working knowledge of ISO 9001:2015 standards.
4. Extensive experience hosting external customer audits and filling out supplier quality questionnaires in a B2B life sciences or CRDMO environment.
5. Experience drafting and negotiating Quality Agreements with clients, with a strong ability to manage customer expectations appropriately for an RUO setting.
6. Expert knowledge of quality risk assessment, CAPA management, and change control methodologies within an RUO or ISO-certified manufacturing environment.
7. Proven track record in establishing or optimizing a quality organization and working collaboratively with R&D, production, and QC groups.
8. Excellent diplomacy, negotiation, and customer-service skills, with the ability to confidently explain and defend quality systems to technical and quality representatives from partner organizations.
9. Strong interpersonal, verbal, and written communication skills.

**Benefit:**

- Medical Insurance/ Vision Insurance/ Dental Insurance
- 401(k) & Retirement Savings Plan (RSP)
- Short Term Disability Insurance
- New Child Leave
- Paid Time Off
- Paid Company Holidays per year
- Paid Sick Days (earned based on hours worked)
- Compassionate Leave
- Jury Duty Leave
- Float day
- Personal days

**Perks:**

- Free colleague meals during shift
- Onsite massages Charis
- Onsite gyms

**Compensation:**

Salary range: $100,000 – $120,000 total compensation, including bonus, depending on experience and qualifications.

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Washington

Frederick National Laboratory for Cancer Research

QA Calibration Specialist III

**QA Calibration Specialist III**

Job ID: req4626

Employee Type: exempt full-time

Division: Vaccine Clinical Materials Program

Facility: Frederick: G-WAY

Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

**Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.**

**PROGRAM DESCRIPTION**

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its’ mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

**KEY ROLES/RESPONSIBILITIES**

- Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production.
- Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
- Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
- Facilitates internal training on quality assurance requirements, processes, and procedures.
- May perform or be part of cross-functional teams performing risk assessments.
- Perform equipment and instrument calibration and testing to meet preapproved specifications and perform adjustments as required.
- Create and maintain all calibration work in the Regulatory Asset Management database used to track the status of instrumentation used in cGMP manufacturing.
- Review executed instrument calibration records.
- Compile data and prepare Master Calibration Records and Instrument Calibration Records.
- Create and revise departmental Standard Operating Procedures (SOPs).
- Generate work orders.
- Print out calibration reports for daily and monthly activities.
- Perform daily updates of completed work in the RAM database.
- Schedule calibration vendors for on-site activities.
- Manage off-site calibrations including working with vendors to obtain quotes and appropriate shipping information.
- Training Calibration Specialist I/II on Calibration principles and execution of complex equipment.

**BASIC QUALIFICATIONS**

**To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:**

- Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field (Qualifying experience (4 years) in Calibration, Validation or Facilities/Engineering may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirement, a minimum of five (5) years of progressively responsible Calibration experience.
- Must possess basic Microsoft Office skills.
- Must understand quality systems compliant with FDA regulations for cGMP.
- Must have a working knowledge of all aspects of calibration.
- Must have experience calibrating controlled temperature units (refrigerators, freezers, incubators) for temperature/humidity/CO2.
- Must have experience calibrating utility systems such as Water For Injection, Steam, and Compressed gases for temperature/pressure.
- Must have experience calibrating equipment such as autoclaves, ovens, and isolators.
- An orientation to teamwork and a commitment to quality and customer satisfaction are essential.
- Must have the ability to clearly summarize and communicate calibration issues to equipment owners and staff.
- Experience in maintaining databases and data entry.
- Experience in writing/investigating Out of Tolerance conditions for equipment.
- Must have good writing skills
- Must be able to obtain gown certification and work aseptically in clean room conditions.
- This position is considered a safety-sensitive position and will be subject to random drug testing per the Leidos Biomedical Research Drug Free Workplace Program.
- Ability to obtain and maintain a security clearance.

**PHYSICAL REQUIREMENTS**

- Physical requirements include the ability to maintain balance at all times, walk, kneel, hear (corrective appliance allowed), use of both hands, arms and legs (prosthetic allowed), use of all fingers, carry up to 50 lbs, reach above shoulders, climb ladders, push/pull, repeated bending and stand for extended periods.
- Ability to respond to verbal instruction and cues in a sterile environment where staff are wearing face masks.
- Ability to wear Personal Protective Equipment (PPE)
- Ability to Enter a Laboratory or Encounter a Hazardous Area
- Ability to Operate and/or service equipment that contacts or transports compressed or liquid gas.
- Ability to withstand exposure to temperatures below 32 degrees indoors for small amounts of time.
- Visual acuity to include depth perception, color distinction, and vision correctable to 20/40.
- Pacemaker prohibited.

**PREFERRED QUALIFICATIONS**

**Candidates with these desired skills will be given preferential consideration:**

- Experience in a cGMP environment.
- Basic knowledge of cGMP requirements as it relates to maintaining calibrated instrumentation.
- Experience with Blue Mountain Regulatory Asset Management database.
- Experience working in an environment regulated by Standard Operating Procedures (SOPs).
- Ability to prepare timelines and project schedules using computer applications.
- Experience with Master Control.
- Experience with electronic Document Management Systems.

**JOB HAZARD**

- This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.

**Commitment to Non-Discrimination**

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

**Pay and Benefits**

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available [here](<https://frederick.cancer.gov/careers/benefits>)

76,800.00 - 110,103.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

\#LI-LR1