Manager, C&Q Document Preparation (Facilities and Utilities)

Responsibilities

• Lead a blended team of employees and contingent workers in preparing compliant, inspection-ready commissioning and qualification (C&Q) documentation.
• Oversee the development of qualification protocols, reports, risk assessments, and traceability matrices for engineering systems and capital projects.
• Partner with Engineering, Validation, Quality, and Manufacturing teams to ensure documentation aligns with project timelines and operational readiness.
• Execute C&Q documentation using established Center of Excellence (CoE) standards and templates to ensure consistency and compliance.
• Monitor documentation progress, identify potential risks, and drive timely resolution of issues impacting project schedules.
• Maintain inspection-ready documentation to support regulatory inspections and internal audits.
• Provide leadership, coaching, and professional development to team members while fostering a culture of quality and accountability.

Requirements

• 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, or technical operations within the pharmaceutical or biotechnology industry.
• Proven experience leading technical teams, including full-time employees and outsourced resources.
• Strong understanding of risk-based qualification methodologies and lifecycle validation approaches.
• Extensive experience preparing or overseeing qualification documentation such as protocols, reports, and risk assessments.
• Deep knowledge of GMP documentation practices, data integrity, and inspection readiness principles.
• Excellent written and verbal communication skills with the ability to translate technical requirements into compliant documentation.

Preferred Qualifications

• Experience working within a Commissioning & Qualification Center of Excellence (CoE) model.
• Familiarity with facilities, utilities, and infrastructure qualification activities in regulated GMP environments.
• Experience supporting global Engineering capital projects.
• Exposure to continuous improvement initiatives focused on documentation quality and operational efficiency.

About the Company

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.