Senior Associate - Commissioning and Qualification (Drug Substance)

Senior Associate C&Q – Drug Substance

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

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Experience Level

Mid Level