CQV Engineer

Keep the Heartbeat of Innovation Running

Join our client to ensure cutting-edge manufacturing never misses a beat. This role supports commissioning, qualification, and validation activities for systems, equipment, and processes throughout their lifecycle. The position involves ensuring compliance with regulatory standards as well as managing technical changes.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities

• Plan, coordinate, and perform initial and periodic qualifications of plant units, systems, and technical equipment.
• Evaluate technical changes, conduct periodic reviews, and support decommissioning activities.
• Prepare, process, and coordinate Technical Change Requests (TCRs).
• Ensure timely handling of deviations, investigations, and CAPAs, assessing their impact on the qualified state.
• Create, review, and release technical and quality-relevant documentation in adherence to GxP requirements.
• Act as a CQV Subject Matter Expert for project teams, engineering, QA, and operations, providing guidance on maintaining the qualified state of systems.
• Represent the department during internal and external audits, customer visits, and regulatory inspections.
• Present CQV documentation and support the resolution of audit findings.

Key Skills and Requirements

• Technical degree or equivalent professional experience in a relevant field.
• Proficiency in Kneat, MS Word, Excel, and PowerPoint.
• High attention to detail, precision, and ability to work independently with minimal supervision.
• Strong verbal and written communication skills, with the ability to collaborate effectively in cross-functional teams.
• Business fluency in German (required) and English (preferred).