Manager, C&Q Document Preparation

Job Description:

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 qualification 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.

Qualification & Expeirence

• 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.