Manager, C&Q Document Preparation (Facilities and Utilities)

Amgen · Hyderabad, India

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Corporate & BusinessFull-timeCompany career page

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Role summary

Lead commissioning and qualification documentation preparation for engineering projects and GMP manufacturing systems at a biotechnology company. Manage a blended team to deliver compliant, inspection-ready documentation while collaborating with cross-functional engineering, validation, quality, and manufacturing teams.

What they're looking for

Bachelor's or Master's degree in Engineering, Life Sciences, or Pharmaceutical Sciences
8–13 years in GMP commissioning, qualification, validation, or engineering in pharmaceutical/biotech
Experience preparing qualification protocols, reports, risk assessments, and traceability matrices
Leadership experience managing full-time employees and contingent or outsourced resources
Strong knowledge of GMP documentation practices, data integrity, and inspection readiness
Project management skills with ability to manage multiple priorities and deadlines
Excellent written and verbal communication skills

What you'll be doing

Lead team responsible for C&Q documentation preparation supporting commissioning and qualification activities across engineering projects
Manage work planning, prioritization, and execution for blended team of employees and contingent resources
Oversee development of qualification protocols, reports, risk assessments, and related documentation
Partner with Engineering, Validation, Quality, Manufacturing, and Project teams to support qualification execution and operational readiness
Monitor documentation progress, identify risks, and drive timely resolution of issues impacting project timelines

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Date posted16 days ago

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