Senior Engineer - Commissioning and Qualification Engineering Lead

Amgen • Holly Springs, NC

7d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll 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 Engineer - Commissioning and Qualification Engineering Lead What you will do Let’s do this. Let’s 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. The project management professional sought for this role will exemplify these values and possess the qualifications outlined below.

Requirements

• High school diploma / GED and 12 years of Commissioning, Qualification, and Validation experience OR
• Associate’s degree and 10 years of Commissioning, Qualification, and Validation experience OR
• Bachelor’s degree and 6 years of Commissioning, Qualification, and Validation experience OR
• Master’s degree and 4 years of Commissioning, Qualification, and Validation experience OR
• Doctorate degree and 4 years of Commissioning, Qualification, and Validation experience

Nice To Haves

• 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.

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees