Senior Qualifying Specialist

Location: Switzerland (100% on-site)
Contract type: Full-time
Language: German (mandatory); English a strong plus

The role

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.