Gesloten vacatures America

Job Title

Lead CQV Engineer – Utilities

Location

Boxmeer, Netherlands

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.

Requirements

• 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.

Desirable Skills

• Experience with large-scale pharmaceutical projects.
• Knowledge of regulatory guidelines (EU GMP, FDA, ICH).
• Ability to work in a fast-paced, project-driven environment.

Contract Details

• Duration: 12 months with possible extension
• Rate: Competitive (based on experience)

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