C&Q Document Preparation Support (Drug Product)
Amgen•19h ago
India - HyderabadOnsiteFull-timeSenior Level5+ yrs exp
Top focus
Vp ProductProduct AnalystProduct ManagerProduct OwnerIt Support
- 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
- 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
- Project teams to develop compliant, inspection-ready documentation that supports commissioning, qualification
- operational readiness activities. This role plays an important part in ensuring documentation quality, consistency
- alignment with established C&Q standards, procedures
- regulatory expectations. This position may support one or more areas including Drug Substance, Drug Product, Finished Drug Product & Packaging
- 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
- efficiency Area-Specific Experience Preferred Experience supporting commissioning and qualification activities for drug product manufacturing systems Familiarity with formulation, compounding, filling, lyophilization
- aseptic processing equipment Understanding of sterile manufacturing practices, contamination control strategies
- cleanroom operations preferred Experience preparing qualification documentation supporting aseptic processing systems and manufacturing operations Familiarity with process equipment qualification including mixers, filling lines, isolators
- autoclaves preferred Experience supporting startup or qualification activities for sterile manufacturing 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 .
Required skills
GMPqualificationvalidationtechnical writingdocumentationrisk assessmentprocess equipment qualificationaseptic processingcleanroom operations