Commissioning & Qualification Engineer for GMP API (HPAPI)

EFOR; Geel; On-site; EUR 70,000 - 90,000; Full time

Job summary

EFOR Group, a trusted Life Sciences consulting partner, is seeking a Commissioning & Qualification Engineer to support a world-leading pharmaceutical company at its Geel API manufacturing site. The role focuses on leading the qualification of complex process equipment and utilities in a GMP environment.

You’ll collaborate with Engineering, Automation, Production and QA to ensure clean handovers, maintain regulatory compliance, and contribute to continuous manufacturing initiatives and the site’s

Qualifications

• 3+ years’ C&Q experience in GMP pharmaceutical, API or fine chemicals environment.
• Hands-on qualification of chemical process equipment (reactors, dryers, centrifuges, containment systems).
• Solid knowledge of cGMP (EU GMP Part II / ICH Q7), Annex 15, GAMP 5 and risk-based qualification.
• Experience with high-potency (HPAPI) containment, ATEX zones or solvent handling is a strong advantage.
• Familiarity with paperless validation tools (e.g. Kneat), DCS/PLC automation (DeltaV, Siemens) or continuous manufacturing is a plus.
• Fluent English; Dutch is a real asset.

Responsibilities

• Lead commissioning and qualification of API process equipment and systems: reactors, centrifuges/filter-dryers, vacuum dryers, mills, isolators and glove boxes
• Qualify supporting utilities and infrastructure, including HVAC, purified water, nitrogen, process piping and solvent systems
• Write and execute C&Q deliverables (URS, system impact and risk assessments, FAT/SAT, commissioning protocols, IQ/OQ/PQ) following ASTM E2500 and a risk-based approach
• Manage discrepancies, deviations and change controls during execution, working closely with vendors, Engineering, Automation, Production and QA
• Support capital projects linked to the site’s move towards continuous manufacturing, digitalisation and its carbon‑neutral 2030 roadmap
• Make sure systems are handed over qualified, documented and inspection‑ready

Skills

C&Q experience

GMP knowledge

DCS/PLC automation

HPAPI containment

Kneat validation

Fluent English

Dutch language

Education

Bachelor’s or Master’s in Chemical/Mechanical/Process/Industrial Engineering

Tools

DeltaV

Siemens

Kneat

Job description

EFOR Group, a trusted Life Sciences consulting partner, is seeking a Commissioning & Qualification Engineer to support a world-leading pharmaceutical company at its Geel API manufacturing site. The role focuses on leading the qualification of complex process equipment and utilities in a GMP environment.

You’ll collaborate with Engineering, Automation, Production and QA to ensure clean handovers, maintain regulatory compliance, and contribute to continuous manufacturing initiatives and the site’s