C&Q Document Preparation Support (Finished Drug Product)
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Career Category
Engineering
Job Description
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
Area-Specific Experience Preferred
Experience supporting commissioning and qualification activities for packaging and finished drug product systems
Familiarity with packaging equipment including labeling, cartoning, serialization, inspection, and automated packaging systems
Experience preparing lifecycle documentation supporting packaging qualification and operational readiness activities
Understanding of GMP requirements related to packaging operations, labeling controls, and serialization systems preferred
Experience supporting commercial manufacturing startup or packaging line qualification activities preferred
Familiarity with integrated packaging systems, vision systems, and automated material handling preferred
Preferred / Good to Have Qualifications & Skills
• Experience in GMP commissioning, qualification, validation, or technical operations
• Experience authoring C&Q 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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Job details
How this role compares
Computed from every other active Manufacturing & CMC role in our database, not just this employer's listings.
We currently track 2556 comparable Manufacturing & CMC roles across 173 biopharma companies.
Salary context
663 of 2556 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 2556 comparable roles
+ 50 more countries
Seniority mix
1172 of 2556 peers have a known seniority level
Therapeutic area mix
12 of 2556 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.