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Package owner cleanroom

Anvers
STAR GROUP
Publiée le 3 juin
Description de l'offre

Responsibilities

1. Lead and manage cleanroom and finishes package delivery from design development through commissioning and qualification for a pharmaceutical manufacturing facility
2. Oversee cleanroom design coordination including HVAC integration, contamination control systems, and specialized finishes meeting EU GMP requirements
3. Manage contractor selection, performance monitoring, and quality control for cleanroom construction activities including wall systems, ceilings, flooring, and critical sealing work
4. Coordinate with validation teams to ensure cleanroom installations meet pharmaceutical qualification standards and regulatory compliance requirements
5. Supervise installation of specialized cleanroom components including air filtration systems, pass-through chambers, and contamination control equipment
6. Ensure compliance with Belgian building codes, EU pharmaceutical regulations, and international cleanroom standards throughout construction phases
7. Manage package budgets, change control processes, and schedule adherence while maintaining quality standards for pharmaceutical-grade installations
8. Facilitate design reviews, technical specifications approval, and coordination meetings with multidisciplinary project teams and regulatory stakeholders
9. Oversee cleanroom commissioning activities including airflow testing, particle counting, and performance qualification protocols

Requirements

10. Experienced in managing cleanroom construction projects, preferably within pharmaceutical or biotechnology industries
11. Strong knowledge of EU GMP requirements, Belgian construction regulations, and international cleanroom standards and classification systems
12. Experience with pharmaceutical facility qualification processes including IQ, OQ, and PQ protocols for cleanroom environments
13. Understanding of HVAC systems integration, contamination control principles, and specialized cleanroom construction techniques
14. Proven track record managing complex technical packages exceeding €M value with multiple stakeholders and regulatory requirements
15. Proficiency in English plus Dutch, and/or French languages desireable for effective communication with Belgian regulatory authorities and project teams
16. Bachelor's degree in Engineering, Architecture, Construction Management, or related technical discipline desireable

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