Commissioning, Qualification & Validation (CQV) Engineer
We’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 do
* Plan 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 bring
* Bachelor’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 have
* Experience 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 offer
* Impactful 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
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Information Technology
Industries
* IT Services and IT Consulting
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