Senior Qualifying Specialist
Location: Switzerland (100% on-site)
Contract type: Full-time
Language: German (mandatory); English a strong plus
Join a growing pharmaceutical site as a CQV Engineer owning validation activities for equipment, systems and facilities. You’ll coordinate installations, author and execute IQ/OQ/PQ protocols, and deliver audit‑ready documentation in line with cGMP/GxP and internal procedures.
What you’ll do
* Plan and coordinate CQV for facilities & utilities (e.g., HVAC, clean/black utilities) and production equipment.
* Author, review, execute and report IQ/IOQ/OQ/PQ protocols and related documentation.
* Produce and maintain validation deliverables: URS, DQ, FMEA, Risk Assessments, FAT, SAT, and final reports.
* Drive gap analyses and continuous improvement across the validation lifecycle; apply lessons learned and regulatory updates.
* Perform Quality Systems activities: Document Management, Change Control, Non‑conformities/Deviations, CAPA; write/revise procedures (SOPs/WIs).
* Support Engineering on validation, re‑qualification and maintenance plans; ensure operational readiness of roll‑outs.
What you bring
* Bachelor’s degree (or higher) in a science/technical field (Biotech, Biochem, Engineering or related).
* 5+ years validation experience in the pharma/biotech industry.
* Hands‑on with IQ/OQ/PQ and validation packages (URS/DQ/FMEA/RA, FAT/SAT).
* Strong cGMP/GxP knowledge and technical writing skills; rigorous documentation and reporting.
* Proven ability to work cross‑functionally and manage timelines across multiple stakeholders.
* German fluency (mandatory); English a strong plus.
* Organized, solution‑oriented, and comfortable working on‑site.
How to apply: Send your CV highlighting IQ/OQ/PQ executions, facilities/utilities scope, and examples of Change Control/CAPA you’ve led.
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Job Details
* Seniority level: Mid‑Senior level
* Employment type: Contract
* Job function: Information Technology
* Industries: IT Services and IT Consulting
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