CQV Clean Utilities Lead (m/w/d)

CQV Clean Utilities Lead (m/f/d)

Responsibilities

• 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.

Qualifications

• 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.

Benefits

• Competitive compensation package
• Opportunities for professional growth and career development
• Collaborative and supportive working environment
• Challenging projects with opportunities to expand your technical expertise
• Ongoing learning and development opportunities
• The opportunity to contribute to high-quality projects in the pharmaceutical and biotechnology sectors