C&Q Document Preparation Support (Drug Substance)

Amgen; Hyderabad; Sur place; INR 700 000 - 1 100 000; Plein temps

Résumé du poste

Amgen Inc. (IR) seeks a Senior Associate specializing in Commissioning & Qualification to join the Engineering C&Q Center of Excellence.

You will prepare, coordinate, and deliver lifecycle documentation for GMP manufacturing systems, partnering with Engineering, Validation, Quality, Manufacturing, Facilities, Automation and Project teams. You will ensure documentation is inspection-ready, compliant with CoE standards, and supports project milestones.

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Engineering or equivalent.
• 5–9 years of IT/pharma related experience preferred.

Responsabilités

• Prepare and revise commissioning and qualification lifecycle documentation supporting projects and systems.
• Author qualification protocols, reports, risk assessments, traceability matrices, test scripts, and related C&Q documentation.
• Support document development 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

Connaissances

GMP Commissioning

C&Q Documentation

Technical Writing

Cross-functional Collaboration

Formation

Bachelor’s degree

Outils

Document Control Systems

Description du poste

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

• Preferred 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

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

Basic Qualifications and Experience:

Bachelor’s or Master’s degree in a relevant field (e.g., Computer Science, Engineering or equivalent). 5–9 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. .

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