About this role
Job title: Senior Associate, Commissioning & Qualification (C&Q)
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 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.
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 drug product manufacturing systems
- Familiarity with formulation, compounding, filling, lyophilization, and aseptic processing equipment
- Understanding of sterile manufacturing practices, contamination control strategies, and cleanroom operations
- Experience preparing qualification documentation supporting aseptic processing systems and manufacturing operations
- Familiarity with process equipment qualification including mixers, filling lines, isolators, and autoclaves
- Experience supporting startup or qualification activities for sterile manufacturing capital projects
- Experience in GMP commissioning, qualification, validation, or technical operations
- Strong written and verbal communication skills; strong organizational skills and attention to detail; experience working in cross-functional project teams
- Knowledge of GMP documentation practices and data integrity requirements
Nice to Have
- Area-Specific Experience Preferred: Experience supporting commissioning and qualification activities for drug product manufacturing systems, familiarity with sterile processing equipment and cleanroom operations, and related areas
- Experience authoring C&Q lifecycle documentation including qualification protocols and reports
- Familiarity with risk-based qualification methodologies and lifecycle validation approaches
- Understanding of GMP documentation practices and data integrity requirements
- Experience working in a fast-paced capital project or startup environment
- Strong written and verbal communication skills, organizational skills, and ability to collaborate across cross-functional teams
Compensation & Benefits
- Salary range: Not disclosed in posting. Benefits and other details not disclosed.