C&Q Document Preparation Support (Facilities & Utilities)

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 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 P&IDs, 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 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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