C&Q Document Preparation Support (Drug Product)

Amgen; Hyderabad; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Amgen Inc. seeks a Senior Associate specializing in Commissioning & Qualification (C&Q) to join the Engineering C&Q Center of Excellence. You will support commissioning lifecycle documentation across GMP systems and partner with multiple departments to ensure inspection-ready records.

The role focuses on high-quality documentation, adherence to C&Q standards, and support for regulatory expectations, potentially across Drug Substance, Drug Product, and Facilities operations.

Qualifications

• Experience in GMP commissioning and qualification documentation.
• Ability to author qualification protocols, reports and risk assessments.
• Familiarity with CoE procedures and templates.

Responsibilities

• Prepare and revise commissioning and qualification lifecycle documentation.
• Author qualification protocols, reports, risk assessments, traceability matrices, test scripts.
• Coordinate review cycles and incorporate comments into final documents.
• Ensure documentation is accurate, complete, compliant, and inspection-ready.
• Collaborate with engineering, validation, quality, manufacturing, facilities, and project teams.
• Track deliverables and support schedules; maintain document version control.
• Support audit and inspection readiness activities; drive continuous improvement.

Skills

GMP commissioning

C&Q documentation

Cross-functional collaboration

Quality systems

Risk assessments

Technical writing

Inspection readiness

Lifecycle documentation

Job description

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 drug product manufacturing systems Familiarity with formulation, compounding, filling, lyophilization, and aseptic processing equipment Understanding of sterile manufacturing practices, contamination control strategies, and cleanroom operations preferred Experience preparing qualification documentation supporting aseptic processing systems and manufacturing operations Familiarity with process equipment qualification including mixers, filling lines, isolators, and 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 .

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen