CQV Engineer

Coopers Group; Oberwallis; On-site; CHF 110,000 - 140,000; Full time

Job summary

Coopers Group is seeking a CQV SME to lead qualification work across lifecycle stages in a GMP-regulated environment. You will coordinate technical changes, ensure traceability of commissioning activities and support audits with clear CQV documentation.

The role requires German and English fluency, a technical degree, and 3–5 years in CQV or related engineering in life sciences. Visp, Switzerland, on‑site position with a long‑term contract potential.

Qualifications

• Fluent in German and English, both written and spoken.
• Experience in CQV, qualification, validation, or engineering in pharma/biotech/life sciences.
• Technical degree or equivalent professional experience.

Responsibilities

• Plan, coordinate, and perform initial and periodic qualifications of plants, units, systems, and equipment across their lifecycle.
• Prepare, process, and coordinate Technical Change Requests (TCRs) and manage deviations, investigations, and CAPAs.
• Create, review, and release CQV documentation in line with GMP and ensure traceability of commissioning activities.
• Act as CQV SME for project teams, Engineering, QA, and Operations; guide on maintaining qualified state.
• Represent the department during internal/external audits, customer visits, and regulatory inspections; address audit findings.

Skills

German (fluent)

English (fluent)

Education

HF / FH / Applied Sciences / University degree or equivalent

Tools

Kneat

MS Word

Excel

PowerPoint

Job description

Location: Visp

Contract start date: As soon as possible

Contract end date: 30 Apr 2027

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.

Requirements

• Technical degree (HF / FH / Applied Sciences / University) or equivalent professional experience in a technical field.
• Fluent German and English
• 3–5 years of professional experience in CQV, qualification, validation, or engineering within the pharmaceutical, biotech, or life sciences industry.
• Experience working in a GMP-regulated manufacturing or laboratory environmen
• Proficient with Kneat, MS Word, Excel, & PowerPoint.