C&Q Document Preparation Support (Drug Substance)

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 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.

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