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Commissioning Lead – CAR-T
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- Lead the commissioning and qualification activities for utility installations, HVAC, and cleanroom environments in compliance with GMP, GAMP, and industry best practices.
- Develop and implement commissioning strategies, protocols, and execution plans for facility expansion projects.
- Oversee the testing, troubleshooting, and validation of systems, ensuring full operational readiness for production.
- Manage and coordinate a team of 15 commissioning professionals, providing leadership, training, and performance oversight.
- Collaborate with cross-functional teams, including Engineering, Quality, Manufacturing, and Validation, to ensure seamless integration of systems.
- Act as the primary liaison between the commissioning team and external contractors, ensuring compliance with safety and regulatory requirements.
- Maintain thorough documentation and reporting to support regulatory audits and inspections.
- Ensure that all commissioning activities align with cleanroom classifications and environmental monitoring requirements.
- Coordinate with the direct manager in Ireland, providing regular updates on project progress and challenges.
Functie-eisen
- Bachelor’s or Master’s degree in Engineering, or a related field.
- 5+ years of experience in commissioning, qualification, or validation in the pharmaceutical or biotechnology industry.
- Proven expertise in HVAC systems, utility installations, cleanroom environments, and GMP-regulated production.
- Strong leadership and team management experience, with the ability to lead and motivate a team of approximately 15 employees.
- Fluent in Dutch and English (both oral and written) to effectively communicate with local and international teams.
- Excellent problem-solving skills, attention to detail, and ability to work in a highly regulated environment.
- Experience in working with manual processes and hands-on commissioning approaches is highly desirable.
Aanbod
A 9 - 12 months full-time Interim Management assignment with a possibility to be prolonged.
A dynamic role in an innovative and growing pharmaceutical company and the opportunity to lead a critical commissioning function in a cutting-edge CAR-T production facility.
If you are a dedicated professional with strong technical and people management skills, we invite you to apply and contribute to the success of the life-saving CAR-T therapy production.
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