CQV Engineer HVAC

Description

• Develop and execute CQV testing documentation for HVAC and Clean Rooms in a sterile drug product facility.
• Ensure GMP Clean Rooms, Cold Rooms, and HVAC systems comply with GMP, company policies, and EU/FDA regulations.
• Commission and test non-GMP HVAC systems to project standards.
• Coordinate with vendors and contractors during commissioning and qualification.
• Manage project deliverables for safety, CQV schedule, and documentation quality.
• Complete required training on time to meet site metrics.
• Perform FAT testing for assigned equipment.
• Handle deviations and implement risk management plans for CQV activities.

Requirements

• Proven ability to implement CQV strategies and execute testing from initiation to completion.
• Hands-on CQV experience with sterile drug manufacturing HVAC and Clean Rooms, including automation systems.
• Experience working in matrix teams and using digital validation platforms (e.g., ValGenesis, Kneat).
• Excellent communication and influencing skills.
• 3–5 years’ pharmaceutical industry experience, ideally with sterile drug product filling line exposure.
• End-to-end CQV lifecycle experience, from design through commissioning and handover.
• Solid background in documentation, execution, and task planning with a track record of timely delivery.
• Innovative mindset with a focus on operational excellence and compliance with BMS policies and regulatory standards.
• Strong understanding of project management processes: scope, design, implementation, and closeout.
• Experience delivering CQV projects safely, on time, and within budget as part of a diverse team.
• Familiarity with startup activities and safety protocols (LOTO, STW, PSSR).
• BS degree in a scientific, technical, or engineering discipline.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance