Senior Engineer Commissioning and Qualification Engineering Lead

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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 Amgens 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 Amgens plan to be a carbon-neutral company by 2027.

Senior Engineer - Commissioning and Qualification Engineering Lead

What you will do

Lets do this. Lets change the world. The C&Q Engineering Lead is responsible for providing strategic leadership technical oversight and operational management for the Equipment & Warehouse (EW) Commissioning and Qualification (C&Q) function. This role ensures compliant efficient and consistent validation practices across departmental capital projects site initiatives and ongoing system lifecycle activities. The position requires strong technical acumen cross-functional collaboration and the ability to drive both local and network-level improvements.

• Serve as Commissioning & Qualification Lead (CQL) for departmental capital projects overseeing C&Q documentation CCMS assessments and project alignment.
• Partner with project leads to scope new work estimate C&Q effort and assign engineering resources.
• Manage the full lifecycle of the validation maintenance program including development of the annual scope of work cost negotiations PO issuance and leading progress meetings.
• Drive inspection readiness by maintaining playbooks responding to inspection IRFs and presenting C&Q/validation topics to auditors.
• Support construction and capital project teams by providing C&Q oversight as the role continues to expand.
• Lead efficiency improvements by developing automation/AI tools for periodic reviews and audit trail assessments.
• Participate in global C&Q validation computerized systems and data integrity networks and share updates with site teams.
• May own and manage C&Q-related deviations as assigned.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The project management professional sought for this role will exemplify these values and possess the qualifications outlined below.

Basic Qualifications:

• High school diploma / GED and 12 years of Commissioning Qualification and Validation experience OR
• Associates degree and 10 years of Commissioning Qualification and Validation experience OR
• Bachelors degree and 6 years of Commissioning Qualification and Validation experience OR
• Masters degree and 4 years of Commissioning Qualification and Validation experience OR
• Doctorate degree and 4 years of Commissioning Qualification and Validation experience

Preferred Qualifications:

• Demonstrated leadership experience in managing technical teams or leading complex cross-functional initiatives.
• Strong understanding of GMP regulations validation lifecycle requirements data integrity principles and C&Q best practices.
• Experience serving as a CQL or validation lead on capital projects.
• Ability to interface with auditors and respond to regulatory inspection requests.
• Familiarity with automated systems CCMS/CMMS platforms and AI/automation tools for compliance workflows.
• Excellent communication stakeholder engagement and decision-making skills.
• Ability to manage competing priorities in a dynamic environment and influence without authority.
• Strong analytical skills and ability to translate technical data into clear actionable insights.
• Prior experience within the pharmaceutical biotechnology or regulated life sciences industry strongly desired.

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!

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.

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