Hyqoo
Commissioning and Qualification (C&Q) Project Manager – Owner’s Representative
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.
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 Details
Seniority level: Mid‑Senior level
Employment type: Contract
Job function: Project Management
Industry: Pharmaceutical Manufacturing
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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.
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 Details
Seniority level: Mid‑Senior level
Employment type: Contract
Job function: Project Management
Industry: Pharmaceutical Manufacturing
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