Manager, C&Q Document Preparation (Manufacturing Support)

India - Hyderabadmid

OtherManager

2 views0 saves0 applied

Apply Now

Quick Summary

Overview

Career CategoryEngineering Job Description About the Role Amgen is seeking a Manager specializing in Commissioning & Qualification (C&Q) to join the Engineering C&Q Center of Excellence (CoE).

Technical Tools

OtherManager

Engineering

About the Role

~1 min read

Amgen is seeking a Manager 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 Manager 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.

Responsibilities

~1 min read

→
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

Nice to Have

~1 min read

Experience supporting commissioning and qualification activities for biotechnology manufacturing systems including upstream and downstream processing equipment
Familiarity with bioprocess equipment such as bioreactors, chromatography skids, filtration systems, centrifuges, and process support systems
Experience supporting CIP/SIP systems and clean process equipment qualification activities
Understanding of GMP documentation requirements related to biologics manufacturing operations
Familiarity with single-use technologies and hybrid manufacturing systems preferred
Experience supporting startup, commissioning, or qualification activities for biotechnology capital projects preferred

Requirements

~1 min read

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

Bachelor’s or Master’s degree in a relevant field (e.g., Computer Science, Engineering or equivalent).
8–13 years of work experience in Information Technology, Information Systems, or a related field
Experience in the global pharmaceutical industry preferred.

EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.