C&Q Document Preparation Support (Drug Product)

Amgen Inc; Hyderabad; On-site; INR 700,000 - 900,000; Full time

Job summary

Amgen Inc is seeking a Senior Associate specializing in Commissioning Qualification to support engineering projects and GMP manufacturing systems. This role involves developing compliance documentation and coordinating with various teams to ensure quality and regulatory standards are met.

The ideal candidate should have experience in GMP commissioning and strong communication skills, ensuring accurate documentation that supports project efficiency and audit readiness.

Qualifications

• Experience in GMP commissioning, qualification, validation, or technical operations.
• Strong written and verbal communication skills.
• Strong organizational skills and attention to detail.

Responsibilities

• Prepare and revise CQ lifecycle documentation for engineering projects.
• Author qualification protocols, reports, and related documentation.
• Ensure documentation is compliant and inspection-ready.
• Track assigned deliverables against project schedules and milestones.

Skills

Technical Writing and Documentation Excellence

Attention to Detail and Quality Focus

Cross‑Functional Collaboration

Planning and Execution

Problem Solving and Analytical Thinking

GMP commissioning

Job description

About the Role

Amgen is seeking a Senior Associate specializing in Commissioning Qualification (CQ) to join the Engineering CQ 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 CQ 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 CQ 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 CQ 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