CQV Engineer

Sector:
Biologics / Pharmaceutical Manufacturing (GMP)
Employment:
Temporary contract, 1 year

Location:

Onsite, 5 days/week
Start:
October 2026
Experience

Required:

8+ 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 - Track Wise 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 life cycles end-to-end, independently.
Leading meetings and presenting progress/status to senior stakeholders.
Managing Track Wise 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.

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