C&Q Document Preparation Support (Drug Substance)
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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 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
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
Basic Qualifications and Experience:
Bachelor’s or Master’s degree in a relevant field (e.g., Computer Science, Engineering or equivalent).
5–9 years of work experience in Information Technology, Information Systems, or a related field
Experience in the global pharmaceutical industry preferred.
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Job details
How this role compares
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We currently track 3428 comparable Manufacturing & CMC roles across 175 biopharma companies.
Salary context
813 of 3428 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
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Seniority mix
1516 of 3428 peers have a known seniority level
Therapeutic area mix
22 of 3428 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
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