C&Q Document Preparation Support (Drug Substance)
Amgen
Career Category
Engineering
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.
Roles & Responsibilities
- 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
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