Amgen
biotechnology
Manager,C&QDocumentPreparation(FacilitiesandUtilities)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Manager, C&Q Document Preparation (Facilities and Utilities) at Amgen. Skills: C&Q documentation preparation, leading blended teams, GMP compliance, project timelines, Center of Excellence (CoE) standards. 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.. Lead a blended team of employees and contingent workers responsible for prepar”
What You'll Achieve.
ensure documentation is delivered with high quality and aligned with project timelines.; enables successful commissioning, qualification, and operational readiness of Engineering systems and capital projects.; drive timely resolution of issues that may impact project timelines.; enhance C&Q documentation quality, efficiency, and compliance.
Industry & Context.
analytical, problem-solving, and decision-making capabilities.
What They're Looking For.
Must Have
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.
Nice to Have
Experience working within a Commissioning & Qualification Center of Excellence (CoE) model., Familiarity with facilities, utilities, and infrastructure qualification activities within regulated GMP environments., 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.
What You'll Do.
Lead the preparation and delivery of commissioning and qualification (C&Q) documentation that supports Engineering project execution and GMP manufacturing
and facility systems across Amgen’s operations.
Lead a blended team of employees and contingent workers responsible for preparing compliant
inspection-ready documentation that enables successful commissioning
and operational readiness of Engineering systems and capital projects.
Works closely with Engineering
and Project teams to ensure documentation is delivered with high quality and aligned with project timelines.
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.
Support one or more areas including Drug Substance
Finished Drug Product & Packaging
or Facilities & Utilities.
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
and execution of deliverables.
Oversee development of qualification protocols
traceability matrices
and related qualification documentation.
Execute C&Q documentation preparation using established CoE standards
and processes to ensure consistency
Partner with Engineering
and Project teams to support qualification execution and operational readiness activities.
Monitor documentation progress
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
and procedures across Engineering projects and sites.
and development for team members while fostering a culture of accountability
and quality execution.
Contribute to continuous improvement initiatives that enhance C&Q documentation quality
How You'll Work.
Team & Collaboration
Works closely with Engineering, Automation, Process Development, Validation, Quality, Manufacturing, Facilities, and Project teams.; Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to support qualification execution and operational readiness activities.; Ability to collaborate effectively across global cross-functional teams.
Communication Scope
Excellent written and verbal communication skills with the ability to translate technical requirements into clear and compliant documentation.; Effective verbal and written communication skills.
Process & Methodology
project management and organizational skills with the ability to manage multiple priorities and deadlines., organizational and time management skills with the ability to manage competing priorities.
Full Job Description
## **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, prioritizat
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