CQV Engineer (German speaker) - 7158

CTC Resourcing Solutions; Oberwallis; Vor Ort; CHF 124.000 - 179.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions is seeking a CQV Engineer for a Visp, Switzerland role on a 6-month contract with extension. Responsibilities include qualification activities across plant lifecycle, handling Technical Change Requests, and maintaining GxP-compliant documentation.

You will act as CQV SME across project teams, QA, and Operations, and support audits and regulatory inspections. Requires 5–10 years of experience, Swiss residency, and English with German B2 proficiency.

Qualifikationen

• Swiss working/residency permit required
• Technical degree (HF / FH / Applied Sciences / University) or equivalent
• 5–10 years of relevant experience
• English with German level B2
• Proficient with Kneat, MS Word, Excel, and PowerPoint
• High attention to detail, independence, self-motivation
• Strong verbal/written communication and cross-functional collaboration

Aufgaben

• Plan, coordinate, and perform qualifications of plants, units, systems, and equipment across their lifecycle.
• Prepare, process, and coordinate Technical Change Requests (TCRs).
• Ensure traceability of commissioning, qualification, and re-qualification activities in compliant documentation.
• Act as CQV SME for project teams, Engineering, QA, and Operations.
• Represent CQV during audits, customer visits, and regulatory inspections.

Kenntnisse

5–10 years experience

English

German B2

Kneat

MS Word

Excel

PowerPoint

Ausbildung

Technical degree (HF / FH / Applied Sciences / University) or equivalent

Tools

Kneat

MS Word

Excel

PowerPoint

Jobbeschreibung

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is recruiting for a CQV Engineer to be based in Visp, Switzerland for a 6 months contract with extension .

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.