Senior Associate, Commissioning & Qualification (C&Q) - Document Preparation Support (Drug Substance)

Job title: Senior Associate, Commissioning & Qualification (C&Q) - Document Preparation Support (Drug Substance)

About the Role Amgen is seeking a Senior Associate 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 Senior Associate 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 position may support one or more areas including Drug Substance, Drug Product, Finished Drug Product & Packaging, or Facilities & Utilities.

What You'll Do

• Prepare and revise commissioning and qualification lifecycle documentation supporting Engineering projects and systems
• Author qualification protocols, reports, risk assessments, traceability matrices, test scripts, and related C&Q documentation
• Support document development activities using approved templates, standards, and CoE procedures
• Coordinate technical review cycles and incorporate comments and revisions into final documents
• Ensure documentation is accurate, complete, compliant, and inspection-ready
• Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to gather technical information
• Track assigned deliverables and support execution against project schedules and milestones
• Maintain document organization and version control within applicable quality systems
• Support audit and inspection readiness activities as required
• Contribute to continuous improvement initiatives focused on documentation quality, consistency, and efficiency

What We're Looking For

• Experience supporting commissioning and qualification activities for biotechnology manufacturing systems including upstream and downstream processing equipment
• Familiarity with bioprocess equipment such as bioreactors, chromatography skids, filtration systems, centrifuges, and process support systems
• Experience supporting CIP/SIP systems and clean process equipment qualification activities
• Understanding of GMP documentation requirements related to biologics manufacturing operations
• Familiarity with single-use technologies and hybrid manufacturing systems preferred
• Experience supporting startup, commissioning, or qualification activities for biotechnology capital projects preferred