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Senior Qualifying Specialist
Randstad - Medium priorityVispSenior Qualifying Specialist
RandstadVispProjektingenieur / in Verfahrenstechnik für biotechnologische Anlagen Visp (m / w / d)
VTUVisp Wallis- Offre sponsorisée
Biotech Process Development Engineer
LonzaMund, Valais, SwitzerlandRecherches associées
Senior Qualifying Specialist
Randstad - Medium priorityVispJobdescription
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.