Senior CQV Engineer

Role Overview

We are looking for a Senior CQV Engineer for a duration of 12 months, to support pharmaceutical manufacturing projects, with primary responsibility for commissioning and qualification of GMP manufacturing equipment. The role requires a hands-on engineering profile capable of independently driving CQV activities from planning and protocol preparation through execution, documentation and handover.

Key Responsibilities

• Lead and coordinate Commissioning & Qualification activities for GMP manufacturing equipment, from commissioning through FAT, SAT, IQ, OQ and PQ.
• Develop, review and execute CQV protocols, test plans, qualification reports and associated technical documentation.
• Provide hands-on technical support during equipment installation, commissioning, start-up and qualification, including troubleshooting and resolution of technical issues.
• Coordinate CQV activities with Engineering, Project Management, Production, equipment suppliers and QA, ensuring milestones and GMP requirements are met.
• Manage qualification documentation, deviations, punch items and technical follow-up through to successful system handover.

Requirements

• Minimum 10 years of Commissioning & Qualification experience, ideally within pharmaceutical or biotech manufacturing.
• Extensive hands-on experience with GMP manufacturing/process equipment.
• Strong practical knowledge of FAT, SAT, IQ, OQ and PQ, including protocol writing and execution.
• Strong engineering and technical background, rather than a profile focused primarily on QA/document review.
• Demonstrated ability to independently manage CQV work packages and coordinate multiple technical stakeholders.
• Solid understanding of GMP requirements and qualification lifecycle principles.
• Fluent German and English are mandatory, both written and spoken.
• Strong communication, coordination and problem-solving skills.