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CQV Engineer – Biologics DSP (interim)

Biologics manufacturer, Pivot Park

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  • Oss, NL · Hybrid
  • Freelance
  • €85–105/h
  • Start: October 2026 · Duration: 9 months, extension likely
  • Ref. BL-1043

Posted

About the role

A biologics site in Oss is adding a second downstream processing suite. The CQV team of four needs a senior engineer to own the chromatography skids and TFF system from FAT through PQ, using a leveraged (ASTM E2500) approach to hit a Q2 2027 PPQ date.

Your responsibilities

  • Lead FAT at the vendor (Germany, two trips) and SAT / commissioning on site
  • Author and execute IQ/OQ protocols reusing commissioning data where justified
  • Manage the punch list with the engineering contractor and automation vendor
  • Support cleaning validation and PPQ readiness for the new suite
  • Present qualification status weekly to the project steering group

What you bring

Must-haves

  • 5+ years CQV on biologics or sterile capital projects
  • Protocol ownership for chromatography, TFF or similar process skids
  • Annex 15 and ASTM E2500 in practice
  • Available 4–5 days per week from October

Nice-to-haves

  • DeltaV or PCS7 automation exposure
  • Cleaning validation (HBEL) experience
  • Dutch conversational

What's offered

  • €85–105 per hour all-in, based on experience
  • Freelance, or secondment through Pharma Recruit
  • 2 days per week remote after commissioning starts
  • Extension into PPQ support likely

About the company

A large-scale biologics manufacturer with over 1,000 staff on the Pivot Park campus, running mammalian upstream and downstream at 2,000 L scale.

How we screen this role

The founder reviews one complete qualification story with you, system, FAT deviations, schedule impact, and checks that you can defend a risk-based reduction in test scope.

Apply for this role

CQV Engineer – Biologics DSP (interim) · BL-1043

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