ABOUT THE ROLE
Amgen is seeking a Manager, Commissioning & Qualification (C&Q) Document Preparation to join the Engineering Commissioning & Qualification (C&Q) Center of Excellence (CoE). In this role, you will lead the preparation and delivery of commissioning and qualification documentation that supports Engineering project execution and GMP manufacturing, packaging, and facility systems across Amgenâs operations.
The manager leads 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 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 protocols, reports, risk assessments, traceability matrices, and related qualification documentation
 Execute C&Q documentation preparation using establishedCoEstandards, 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
Monitordocumentation progress,identifyrisks, and drivetimelyresolution of issues that mayimpactproject timelines
Maintaininspection-ready documentation and support regulatory inspections and internal audits asrequired
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
PREFERRED/GOOD TO HAVE QUALIFICATIONS & SKILLS
Bachelors or Masters degree
8-13 Years of work experience in the relevant field
Experience in GMP commissioning, qualification, validation, or technical operations in a regulated pharmaceutical or biotechnology environmentÂ
Experience preparing or overseeing C&Q documentation including qualification protocols, reports, risk assessments, traceability matrices, and testing documentation
Experience supporting commissioning and qualification activities for manufacturing systems, packaging equipment, or facilities and utilities
 Experience leading technical teams including full-time employees and contingent or outsourced resources
Strong understanding ofrisk-based qualification methodologies and lifecycle validation approaches
Knowledge ofGMP documentation practices, data integrity expectations, and inspection readiness principles
Experience collaborating acrossEngineering, 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
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