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.
Job Tags
For contractors, Flexible hours,