Jobdescription
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.