Manager, C&Q Document Preparation (Drug Substance)

Career Category

Engineering

Job Description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role 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.

• The Manager, C&Q Document Preparation will lead a blended team of employees and contingent workers responsible for preparing compliant, inspection-ready documentation that enables successful commissioning, qualification, and operational readiness of Engineering systems and capital projects.

• This role works closely with Engineering, Automation, Process Development, Validation, Quality, Manufacturing, Facilities, and Project teams to ensure documentation is delivered with high quality and aligned with project timelines.

• This position plays a key role in executing standardized C&Q documentation practices within the Center of Excellence (CoE) and supporting consistent documentation quality across Engineering projects and sites.

• This position may support one or more areas including Drug Substance, Drug Product, Finished Drug Product & Packaging, or Facilities & Utilities

Roles & Responsibilities:

• 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.

Basic Qualifications and Experience:

• 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.

Functional Skills (Must Have):

• 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.

Good-to-Have Skills:

• Experience working within a Commissioning & Qualification Center of Excellence (CoE) model.

• Familiarity with Drug Substance manufacturing systems, process equipment, 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

Soft Skills:

• Strong leadership and team management skills.

• Effective verbal and written communication skills.

• Ability to collaborate effectively across global cross-functional teams.

• Strong analytical, problem-solving, and decision-making capabilities.

• Strong organizational and time management skills with the ability to manage competing priorities.

• Ability to foster a culture of accountability, collaboration, and quality execution.

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.

.