CQV Engineer

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

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.