Functieomschrijving
* 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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