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vor 2 Wochen

Visp, Schweiz Randstad Vollzeit

Jobdescription About the roleWe’re looking for a CQV Engineer to drive the validation of equipment, systems, and facilities in a regulated pharmaceutical environment. You will coordinate installations, author and execute IQ/OQ/PQ protocols, and document results in compliance with cGMP/GxP requirements—ensuring our operations are safe, compliant, and inspection-ready. What you’ll doPlan and coordinate CQV activities for facilities & utilities (e.g., HVAC, cleanrooms, WFI, clean steam) and production equipment. Author, review, and maintain validation deliverables: URS, DQ, FMEA, Risk Assessments, FAT, SAT, IQ, IOQ/OQ, PQ and final reports. Execute IQ/OQ/PQ testing, collect and analyze data, and produce clear, audit-ready documentation. Apply validation lifecycle principles; perform gap analyses and risk assessments; identify efficiencies and lessons learned. Monitor regulatory expectations; implement updates to keep programs aligned with cGMP/Annex 15 and internal SOPs. Support Quality Systems activities: Document Management, Change Control, Deviations/Non-conformities, and CAPAs. Collaborate cross-functionally (Engineering, Production, QA, EHS) and help shape requalification and preventive maintenance plans. Write and/or revise procedures related to engineering and validation activities. What you’ll bringBachelor’s degree in a scientific or technical discipline (Engineering, Life Sciences or similar). 5–10 years of CQV/validation experience in the pharma/biotech industry. Hands-on expertise with IQ/OQ/PQ, URS/DQ/FMEA/Risk Assessments, FAT/SAT, and cGMP documentation. Strong understanding of facilities/utilities validation and applicable regulations/standards. Excellent technical writing and communication skills; comfortable working cross-functionally. Outstanding organization and time management; able to manage multiple workstreams and deadlines. Language: English (required) and German (required) Nice to haveExperience with electronic quality systems (e.g., Veeva, TrackWise, MasterControl). Exposure to data integrity principles (ALCOA+), Annex 11/Part 11, and CSV/CSA approaches. Familiarity with statistical tools for validation and risk-based methodologies. What we offerImpactful work in a highly regulated, patient-focused environment. Collaborative team culture with strong Quality partnership. Opportunity to optimize and modernize validation programs. How to apply: Send your CV (and earliest start date). We review applications on a rolling basis

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