CQV Clean Utilities Lead (m/w/d)

Lead commissioning, qualification and validation (CQV) activities for clean utility systems, including WFI, purified water, clean steam and process gases.

Develop and review qualification protocols, technical documentation and risk assessments in compliance with cGMP and applicable regulatory standards.

Coordinate with engineering, quality, construction and operations teams to ensure successful system installation, testing and handover.

Manage deviations, change controls and troubleshooting throughout commissioning and qualification activities.

Ensure project milestones are met while providing technical guidance and support to junior team members.

Bachelor’s degree in Engineering, Life Sciences or a related discipline.

Minimum 8 years of experience in CQV of clean utility systems within the pharmaceutical or biotechnology industry.

Strong knowledge of clean utility systems, cGMP, FDA requirements and relevant EU GMP guidelines.

Proven experience with IQ/OQ/PQ protocols, technical documentation, risk assessments and change control.

Excellent communication, organizational and project management skills.

Experience with large-scale capital projects, vendor management or computerized system validation is an advantage.