Career Category
Engineering
Job Description
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 Amgen’s 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 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
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 environment
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 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
.
