Commissioning and Qualification (C&Q) Project Manager

Position: Commissioning and Qualification (C&Q) Project Manager

Location: Conshohocken, PA (onsite 2-3 days is mandatory)

Position Summary
Reporting to the Project CQV Lead, the Commissioning and Qualification (C&Q) Project Manager is responsible for developing and executing the project s C&Q strategy, ensuring delivery within scope, schedule, and budget. This role oversees the C&Q team and all related activities to ensure assets are started up, tested, and qualified for compliant, reliable operation. The C&Q Project Manager will ensure processes meet business needs while adhering to regulatory and quality standards.

Key Responsibilities

• Develop and implement a risk-based C&Q strategy for all GMP (direct impact) and non-GMP (indirect impact) systems and assets, aligned with current industry practices.
• Provide input across all project phases, including design, construction, operational readiness, and technical operations.
• Lead and manage a team of approximately 15 C&Q Engineers to deliver scope for facilities, utilities, and process equipment.
• Oversee the development and execution of C&Q documentation in compliance with internal quality standards, cGMP requirements, and client procedures.
• Ensure team safety and compliance with site safety protocols.
• Coordinate and schedule project activities, mentor team members, and review deliverables.
• Collaborate with stakeholders to ensure an effective, efficient, and compliant C&Q program.
• Participate in system and equipment design reviews to ensure GMP compliance.
• Align C&Q strategy with business and project stakeholders and foster strong cross-functional relationships (Construction, Automation, Technical Operations).
• Contribute to automation strategy and software design.
• Implement digital C&Q processes using KNEAT software for documentation and workflows.
• Manage change control activities in accordance with site procedures.
• Identify and implement best practices to enhance business and technical processes.