Commissioning, Qualification & Validation (CQV) Engineer

About the role

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