CQV Engineer

Main Responsibilities:

• Qualification & Re-qualification: Plan, coordinate, and perform initial and periodic qualifications of plants, units, systems, and technical equipment across their lifecycle. Evaluate technical changes, conduct periodic reviews, and support decommissioning activities.
• Technical Changes & Deviation Management: Prepare, process, and coordinate Technical Change Requests (TCRs). Ensure timely handling of deviations, investigations, and CAPAs, assessing their impact on the qualified state.
• Documentation & Compliance: Create, review, and release technical and quality-relevant documentation adhering strictly to GxP requirements. Ensure full traceability of all commissioning, qualification, and re-qualification activities.
• Subject Matter Expertise (SME): Act as CQV Subject Matter Expert for project teams, Engineering, QA, and Operations. Provide guidance on technical measures and maintaining the qualified state of systems.

·Audit & Inspection Support: Represent the department during internal/external audits, customer visits, and regulatory inspections. Present CQV documentation and support resolution of audit findings

Qualifications and Experience:

·Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required

·Technical degree (HF / FH / Applied Sciences / University) or equivalent professional experience in a technical field.

·5–10 years of relevant experience required

·Good level of English with minimum German level B2

·Proficient with Kneat, MS Word, Excel, and PowerPoint.

·High attention to detail, precision, ability to work independently with minimal direct supervision, self-motivated, and proactive.

·Strong verbal/written communication and ability to collaborate in cross-functional teams.