Job Description

Job Description

Location: Spring House, Pennsylvania, United States

Job Description:

The Commissioning and Qualification (C&Q) Project Manager – Owner’s Representative reports to the Project CQV Lead and is responsible for developing and executing the project’s C&Q strategy to ensure 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 ensures that 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.

Key Competencies

• Strong leadership, interpersonal, and communication skills.
• Ability to work collaboratively in a team environment.
• Excellent organizational and problem-solving skills with attention to detail.
• Results-driven, adaptable, and flexible.
• Commitment to ethical decision-making and fostering an inclusive, respectful work environment.
• Ability to assess and communicate risks, ensuring compliance with quality standards.
• Accountability for personal performance and development while supporting team growth.
• Openness to diverse perspectives and ability to engage in constructive dialogue.
• Enterprise mindset with the ability to prioritize and deliver results effectively.

Qualifications

Required:

• Bachelor’s degree in an engineering-related discipline.
• 10+ years of experience in Cell and Gene Therapy, Drug Product Biotech, and/or OSD pharmaceutical manufacturing.
• 10–15 years of C&Q experience with a proven track record in cGMP-regulated environments.
• Experience as C&Q Lead on at least one major Cell and Gene Therapy or Biotech project.
• Strong planning, organizational, and influencing skills.
• Excellent written and verbal communication skills.

Preferred:

• Experience with digital C&Q systems (e.g., KNEAT).
• In-depth knowledge of C&Q regulations and standards.
• Ability to work under pressure and meet deadlines.
• Demonstrated ability to lead teams and coordinate contractors and consultants.

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