C&Q Document Preparation Support (Facilities & Utilities)

Amgen; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amgen is seeking a Senior Associate in Commissioning & Qualification (C&Q) to join the Engineering C&Q Center of Excellence. The role supports lifecycle documentation across GMP manufacturing systems, partnering with Engineering, Validation, Quality, Manufacturing, Facilities, Automation and Project teams to ensure compliant, inspection-ready deliverables.

Responsibilities include authoring protocols and reports, coordinating reviews, and maintaining document control.

Qualifications

• Experience in GMP commissioning, qualification, validation or related technical operations.
• Strong written and verbal communication skills for documentation.
• Ability to work across Engineering, Validation, Quality, Manufacturing and Facilities teams.
• Familiarity with lifecycle documentation and regulatory expectations.

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.
• Ensure documentation is accurate, compliant, and inspection-ready.
• Support audit and inspection readiness activities as required.
• Contribute to continuous improvement of documentation quality and efficiency.

Skills

GMP C&Q experience

Technical writing

Cross-functional collaboration

Documentation standards

Inspection readiness

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 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

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