Manager, Commissioning & Qualification (C&Q) Document Preparation - Drug Substance

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