Package Owner Cleanroom

Responsibilities

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

Requirements

• Experienced in managing cleanroom construction projects, preferably within pharmaceutical or biotechnology industries
• Strong knowledge of EU GMP requirements, Belgian construction regulations, and international cleanroom standards and classification systems
• Experience with pharmaceutical facility qualification processes including IQ, OQ, and PQ protocols for cleanroom environments
• Understanding of HVAC systems integration, contamination control principles, and specialized cleanroom construction techniques
• Proven track record managing complex technical packages exceeding €20M value with multiple stakeholders and regulatory requirements
• Proficiency in English plus Dutch, and/or French languages desireable for effective communication with Belgian regulatory authorities and project teams
• Bachelor's degree in Engineering, Architecture, Construction Management, or related technical discipline desireable