CQ Engineer
Il y a 2 semaines
Geel, Flanders, Belgique
EFOR
Temps plein
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đ Now Hiring: CQ Engineer â API Manufacturing (Geel, Belgium | Onsite)
Does qualifying a high-containment reactor train sound more exciting than another cleanroom? EFOR Group, a trusted Life Sciences consulting partner, is looking for a Commissioning & Qualification Engineer to support a world-leading pharmaceutical company at its large-scale Active Pharmaceutical Ingredient (API) manufacturing site in Geel, where chemistry, high-potency handling and digital innovation meet.
What you'll do
âą Lead commissioning and qualification of API process equipment and systems: reactors, centrifuges/filter-dryers, vacuum dryers, mills, isolators and glove boxes
âą Qualify supporting utilities and infrastructure, including HVAC, purified water, nitrogen, process piping and solvent systems
âą 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
âą Manage discrepancies, deviations and change controls during execution, working closely with vendors, Engineering, Automation, Production and QA
âą Support capital projects linked to the site's move towards continuous manufacturing, digitalisation and its carbon-neutral 2030 roadmap
âą Make sure systems are handed over qualified, documented and inspection-ready Your background:
âą Bachelor's or Master's in Chemical, Mechanical, Process or Industrial Engineering, or a related field
âą 3+ years' C&Q experience in a GMP pharmaceutical, API or fine chemicals environment
âą Hands-on qualification of chemical process equipment (reactors, dryers, centrifuges, containment systems)
âą Solid knowledge of cGMP (EU GMP Part II / ICH Q7), Annex 15, GAMP 5 and risk-based qualification
âą Experience with high-potency (HPAPI) containment, ATEX zones or solvent handling is a strong advantage
âą Familiarity with paperless validation tools (e.g. Kneat), DCS/PLC automation (DeltaV, Siemens) or continuous manufacturing is a plus
âą Fluent English; Dutch is a real asset Why EFOR Group? EFOR brings together more than 3,200 experts in 18 countries, delivering technical, quality and engineering excellence across the full Life Sciences product lifecycle. Join a team helping to make the medicines of tomorrow, more safely and more sustainably. đ
Location:
Geel, Belgium (onsite) đ Ready to qualify the chemistry behind life-changing medicines? APPLY NOW or get in touch. Interviews are ongoing #LifeSciences #CQ #Commissioning #Qualification #API #ChemicalEngineering #HPAPI #Pharma #GeelJobs #Belgium #TeamEFOR #NowHiring
What you'll do
âą Lead commissioning and qualification of API process equipment and systems: reactors, centrifuges/filter-dryers, vacuum dryers, mills, isolators and glove boxes
âą Qualify supporting utilities and infrastructure, including HVAC, purified water, nitrogen, process piping and solvent systems
âą 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
âą Manage discrepancies, deviations and change controls during execution, working closely with vendors, Engineering, Automation, Production and QA
âą Support capital projects linked to the site's move towards continuous manufacturing, digitalisation and its carbon-neutral 2030 roadmap
âą Make sure systems are handed over qualified, documented and inspection-ready Your background:
âą Bachelor's or Master's in Chemical, Mechanical, Process or Industrial Engineering, or a related field
âą 3+ years' C&Q experience in a GMP pharmaceutical, API or fine chemicals environment
âą Hands-on qualification of chemical process equipment (reactors, dryers, centrifuges, containment systems)
âą Solid knowledge of cGMP (EU GMP Part II / ICH Q7), Annex 15, GAMP 5 and risk-based qualification
âą Experience with high-potency (HPAPI) containment, ATEX zones or solvent handling is a strong advantage
âą Familiarity with paperless validation tools (e.g. Kneat), DCS/PLC automation (DeltaV, Siemens) or continuous manufacturing is a plus
âą Fluent English; Dutch is a real asset Why EFOR Group? EFOR brings together more than 3,200 experts in 18 countries, delivering technical, quality and engineering excellence across the full Life Sciences product lifecycle. Join a team helping to make the medicines of tomorrow, more safely and more sustainably. đ
Location:
Geel, Belgium (onsite) đ Ready to qualify the chemistry behind life-changing medicines? APPLY NOW or get in touch. Interviews are ongoing #LifeSciences #CQ #Commissioning #Qualification #API #ChemicalEngineering #HPAPI #Pharma #GeelJobs #Belgium #TeamEFOR #NowHiring