Amgen · 1 month ago
Senior Engineer - Commissioning and Qualification Engineering Lead
Holly Springs, NC
Full-time
Onsite
Senior Level, Lead/Staff
4+ years expAmgen is a leading biotechnology company dedicated to serving patients with serious illnesses. The Senior Engineer - Commissioning and Qualification Engineering Lead will provide strategic leadership and technical oversight for the Equipment & Warehouse Commissioning and Qualification function, ensuring compliant and efficient validation practices across projects and initiatives.
BiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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
Preferred
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
Benefits
Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
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