Vacature - Jouw nieuwe functie
Director - Engineering & Facilities
QTC are partnered with an innovative and rapidly growing advanced therapies manufacturer in seeking a Director of Engineering & Facilities to lead the delivery of a new GMP manufacturing facility.
This is a unique greenfield leadership opportunity, offering end-to-end responsibility for facility construction, commissioning, qualification, startup, and long-term operational leadership. The successful candidate will play a critical role in building the site's engineering organization and ensuring operational readiness for commercial manufacturing.
Biotechnical
Facilities Management
Leiden - Netherlands
40 uur per week
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Jouw consultant
Over jouw rol
Zo maak jij het verschil
- Act as the site lead for the construction and delivery of a new GMP manufacturing facility.
- Manage project budget, schedule, risk, and contractor performance.
- Oversee engineering design reviews, construction activities, change management, and project controls.
- Coordinate permitting activities and interactions with local authorities and external stakeholders.
- Lead commissioning, qualification, and startup activities through operational handover.
- Develop and implement the site's Engineering & Facilities strategy.
- Establish and lead Facilities Engineering, Maintenance, Reliability, Calibration/Metrology, and Site Services functions.
- Ensure facilities, utilities, equipment, and infrastructure remain compliant with GMP requirements.
- Implement maintenance and asset lifecycle programs, including CMMS and site systems.
- Build and develop a high-performing Engineering & Facilities organization.
- Recruit, coach, and mentor technical teams during site startup and growth phases.
- Establish performance metrics, training programs, and succession planning.
- Maintain an inspection-ready facility and support regulatory inspections and audits.
Wat nodig is
Wat jij mee brengt
- Bachelor's degree in Engineering or related technical discipline.
- 10+ years of Engineering & Facilities experience within biotech, biopharmaceutical, pharmaceutical, biologics, cell therapy, gene therapy, or related GMP environments.
- Demonstrated experience leading greenfield facility builds, site expansions, or major capital projects.
- Proven success managing engineering teams, contractors, and complex stakeholder environments.
- Experience supporting facility startup, commissioning, qualification, and validation activities.
- Expertise in cleanrooms, HVAC systems, pharmaceutical utilities, facility infrastructure, and process equipment.
- Experience with CQV (Commissioning, Qualification & Validation), maintenance strategies, reliability programs, and asset management systems.
- Strong knowledge of CAPEX project execution and contractor management.
- Ability to lead within a fast-paced, growth-oriented environment.
- Strategic thinker with hands-on execution skills
Wat wij bieden
Jouw voordelen
- Opportunity to lead the delivery and startup of a state-of-the-art GMP manufacturing facility.
- High-impact leadership role with significant visibility and influence.
- Chance to build an engineering organization from the ground up.
- Collaborative international environment within a rapidly growing advanced therapies sector.
- Competitive executive-level compensation package including bonus and long-term growth opportunities.
- Relocation support may be available for exceptional candidates.
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