About the role
About the Role
Amgen is seeking a Senior Associate specializing in Commissioning Qualification (CQ) to join the Engineering CQ 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 CQ 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 CQ 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
Area-Specific Experience Preferred
- Experience supporting commissioning and qualification activities for GMP facilities and utility systems
- Familiarity with Plant Utilities, HVAC systems, water systems, clean utilities, environmental monitoring support systems, and facility infrastructure
- Experience preparing lifecycle documentation for utility and infrastructure qualification activities
- Understanding of system turnover, startup, and commissioning documentation practices
- Familiarity with facility design and engineering documentation including PIDs, system boundaries, and turnover packages preferred
- Experience supporting startup or qualification activities for GMP facility or infrastructure capital projects preferred
- Knowledge of clean utility systems including WFI, clean steam, compressed gases, and building management systems preferred
Preferred / Good to Have Qualifications Skills
Experience in GMP commissioning, qualification, validation, or technical operations
Experience authoring CQ lifecycle documentation including qualification protocols and reports
Familiarity with risk-based qualification methodologies and lifecycle validation approaches
Knowledge of GMP documentation practices and data integrity requirements
Experience working in a fast-paced capital project or startup environment preferred
Strong written and verbal communication skills
Strong organizational skills and attention to detail
Experience working in cross-functional project teams
Key Competencies
Technical Writing and Documentation Excellence
Attention to Detail and Quality Focus
Cross-Functional Collaboration
Planning and Execution
Problem Solving and Analytical Thinking
Continuous Improvement Mindset
Communication and Stakeholder Partnership
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