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Amgen Logo Amgen · -

Manager, C&Q Document Preparation (Drug Product)

India, Hyderabad · Job Posted May 14, 2026
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Job Description

In this vital role, you will lead the preparation and delivery of commissioning and qualification (C&Q) documentation that supports Engineering project execution and GMP manufacturing, packaging, and facility systems across Amgen’s operations.

Job Responsibility

  • Lead a team responsible for preparation and delivery of C&Q documentation supporting commissioning and qualification activities across Engineering projects and systems
  • Manage work across a blended team of employees and contingent resources, ensuring effective planning, prioritization, and execution of deliverables
  • Oversee development of qualification protocols, reports, risk assessments, traceability matrices, and related qualification documentation
  • Execute C&Q documentation preparation using established CoE standards, templates, and processes to ensure consistency, compliance, and efficiency
  • Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to support qualification execution and operational readiness activities
  • Monitor documentation progress, identify risks, and drive timely resolution of issues that may impact project timelines
  • Maintain inspection-ready documentation and support regulatory inspections and internal audits as required
  • Support implementation of standardized C&Q practices, templates, and procedures across Engineering projects and sites
  • Provide leadership, coaching, and development for team members while fostering a culture of accountability, collaboration, and quality execution
  • Contribute to continuous improvement initiatives that enhance C&Q documentation quality, efficiency, and compliance

Requirements

  • Bachelor’s or master’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field
  • 8-13 years of experience in GMP commissioning, qualification, validation, engineering, or technical operations within the pharmaceutical or biotechnology industry
  • Experience supporting commissioning and qualification activities for manufacturing systems, packaging equipment, or facilities and utilities
  • Experience preparing or overseeing qualification documentation including protocols, reports, risk assessments, traceability matrices, and testing documentation
  • Experience working in regulated GMP manufacturing environments with knowledge of inspection readiness and compliance expectations
  • Strong understanding of GMP commissioning, qualification, and validation practices within regulated pharmaceutical or biotechnology environments
  • Experience leading technical teams including full-time employees and contingent or outsourced resources
  • Strong understanding of risk-based qualification methodologies and lifecycle validation approaches
  • Knowledge of GMP documentation practices, data integrity expectations, and inspection readiness principles
  • Experience collaborating across Engineering, Validation, Quality, Manufacturing, Facilities, and Project Management teams
  • Strong project management and organizational skills with the ability to manage multiple priorities and deadlines
  • Excellent written and verbal communication skills with the ability to translate technical requirements into clear and compliant documentation
  • Experience using standardized templates, processes, and procedures to support consistent C&Q documentation practices

Nice to have

  • Experience working within a Commissioning & Qualification Center of Excellence (CoE) model
  • Familiarity with Drug Product manufacturing systems, packaging systems, facilities, and utilities qualification activities
  • Experience supporting global Engineering capital projects in pharmaceutical or biotechnology environments
  • Exposure to continuous improvement initiatives focused on documentation quality, operational efficiency, and compliance
  • Knowledge of regulatory expectations related to commissioning, qualification, and validation activities

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