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

C&Q Document Preparation Support (Finished Drug Product)