Manager, C&Q Document Preparation (Manufacturing Support)
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From Amgen’s original posting
Career Category Engineering Job Description About the Role Amgen is seeking a Manager specializing in Commissioning & Qualification (C&Q) to join the Engineering C&Q Center of Excellence (CoE). In this role, you will support the preparation, coordination, and delivery of commissioning and qualification lifecycle documentation supporting engineering projects and GMP manufacturing systems across Amgen operations. The Manager will partner closely with Engineering, Validation, Quality, Manufacturing, Facilities, Automation, and Project teams to develop compliant, inspection-ready documentation that supports commissioning, qualification, and operational readiness activities. This role plays an important part in ensuring documentation quality, consistency, and alignment with established C&Q standards, procedures, and regulatory expectations. This position may support one or more areas including Drug Substance, Drug Product, Finished Drug Product & Packaging, or Facilities & Utilities. Roles & Responsibilities • Prepare and revise commissioning and qualification lifecycle documentation supporting Engineering projects and systems • Author qualification protocols, reports, risk assessments,…
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