CQV Engineer: Lifecycle Validation Lead (Germany/EU)

Proclinical; Oberwallis; On-site; CHF 110,000 - 150,000; Full time

Job summary

Proclinical is seeking a CQV Engineer to support commissioning, qualification, and validation activities for systems, equipment, and processes throughout their lifecycle. The role requires ensuring regulatory compliance and managing technical changes, with the right to work in Switzerland or EU passport.

Proclinical is acting as an Employment Agency in relation to this vacancy. The candidate will plan, coordinate, and perform qualifications; evaluate changes; prepare TCRs; handle deviations and

Qualifications

• Plan, coordinate, and perform qualifications of plant units and equipment.
• Evaluate changes, conduct periodic reviews, and support decommissioning.
• Prepare, process, and coordinate Technical Change Requests (TCRs).
• Ensure timely handling of deviations, investigations, and CAPAs, assessing impact on qualified state.
• Create, review, and release CQV documentation per GxP requirements.
• Act as CQV SME for project teams, QA, and operations, guiding on maintain qualified state.
• Represent department during audits, customer visits, and regulatory inspections.

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.

Skills

Attention to detail

Independent work

Excellent communication

Education

Technical degree or equivalent experience

Tools

Kneat

MS Word

MS Excel

MS PowerPoint

Job description

Proclinical is seeking a CQV Engineer to support commissioning, qualification, and validation activities for systems, equipment, and processes throughout their lifecycle. The role requires ensuring regulatory compliance and managing technical changes, with the right to work in Switzerland or EU passport.

Proclinical is acting as an Employment Agency in relation to this vacancy. The candidate will plan, coordinate, and perform qualifications; evaluate changes; prepare TCRs; handle deviations and