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Industry: Pharmaceutical / Biopharmaceutical
Role Overview We are seeking an experienced Lead CQV (Commissioning, Qualification & Validation) Engineer with a strong background in utilities systems to support a major pharmaceutical facility project in the Netherlands. The successful candidate will lead CQV activities for utilities, ensuring compliance with GMP standards and project timelines.
Key Responsibilities
- Lead and manage CQV activities for utilities systems (e.g., clean utilities, black/grey utilities, HVAC, WFI, steam, compressed air).
- Develop and execute commissioning and qualification protocols (IQ/OQ/PQ) in line with project requirements and regulatory standards.
- Oversee equipment start-up, FAT/SAT, and ensure proper integration into the facility.
- Perform risk assessments for equipment and processes, ensuring adherence to validation lifecycle principles.
- Coordinate with cross-functional teams, vendors, and contractors to ensure timely delivery of CQV milestones.
- Provide technical leadership and guidance to junior engineers and project teams.
- Ensure compliance with GMP, EHS, and company quality standards throughout the project.
- Prepare and maintain documentation for audits and regulatory inspections.
- Minimum 10+ years of experience in CQV within pharmaceutical or biopharmaceutical facilities.
- Proven expertise in utilities systems (clean/black/grey utilities, HVAC, WFI, steam, etc.).
- Strong knowledge of commissioning, qualification, and validation processes (IQ/OQ/PQ).
- Experience with equipment start-up and integration in GMP environments.
- Familiarity with risk-based approaches and validation lifecycle principles.
- Excellent communication and leadership skills; ability to manage stakeholders and vendors.
- EU work authorization (preferred).
- Willingness to relocate to Boxmeer, Netherlands.
- Experience with large-scale pharmaceutical projects.
- Knowledge of regulatory guidelines (EU GMP, FDA, ICH).
- Ability to work in a fast-paced, project-driven environment.
- Duration: 12 months with possible extension
- Rate: Competitive (based on experience)
The NRL Group connect global companies with the right people to bring engineering projects to life. Supporting contracting companies with energy transition plans and working with our clients to create a cleaner, greener future.
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