CQV Engineer (Utilities / USP-DSP)
Sector: Biologics / Pharmaceutical Manufacturing (GMP)
Employment: Temporary contract, 1 year
Location: Onsite, 5 days/week
Start: October 2026
Experience Required: 6+ years relevant experience
Education: Chemical/Engineering, Biotechnology, or Pharmaceutical Engineering background
MUST HAVE
- Proven track record independently driving, owning, and closing out multiple full CQV projects, covering commissioning, qualification, validation lifecycle, IQ/OQ/PQ execution, protocol writing/review, validation reports, and close-out.
- Scope in EITHER:
- Utilities: WFI, clean steam, HVAC, clean gases, purified water, process utilities
- OR USP/DSP equipment: bioreactors, single-use systems, media prep, seed trains, cell culture (upstream) / chromatography, TFF, filtration, purification (downstream)
- Strong GMP Quality Systems ownership - TrackWise change controls, deviations, CAPAs, risk assessments, investigation support.
- Excellent project management skills, from kickoff through close-out.
- Experience with GMP requirements and FDA/EMA regulations, particularly in biologics.
- Strong presentation and communication skills, including presenting to senior leadership.
- Good written and spoken English (Dutch a bonus).
WHAT YOU'LL ACTUALLY BE DOING
- Owning full CQV project lifecycles end-to-end, independently.
- Leading meetings and presenting progress/status to senior stakeholders.
- Managing TrackWise change controls and deviations to a high quality standard.
- Working under high-stress conditions and tight deadlines.
- Operating with autonomy onsite, five days a week.
WORK STYLE THAT FITS
- Genuinely independent operator - comfortable owning a project without heavy oversight.
- Resilient under deadline pressure and high-stakes GMP environments.
- Confident communicator at senior/leadership level, not just peer-to-peer.
- Detail-oriented but able to see the bigger quality/compliance picture, not just execute steps.
STRONGLY PREFERRED BACKGROUND
- Biologics manufacturing experience - mammalian cell culture, biotech facilities, large molecule production.