Jobdescription
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