Biopharmaceutical Process Engineer

Biopharmaceutical Process Engineer in Leiden voor een wereldwijde farmaorganisatie, gericht op GMP-compliance en equipment reliability.

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Bekijk bij SIRE Life Sciences B.V. (opent in een nieuw tabblad)

Eisen

  • Proactieve, georganiseerde en verantwoordelijke werkstijl
  • Sterke equipment troubleshooting en analytische vaardigheden
  • Sterke stakeholdercommunicatievaardigheden
  • Kennis van GMP-vereisten
  • Minimaal 3 jaar biopharmaceutical processing ervaring met een Bachelor diploma
  • Minimaal 1,5 jaar relevante ervaring met een Master diploma
  • Professionele Engelse taalvaardigheid op B2-niveau
  • Vermogen om root cause analysis uit te voeren en praktische oplossingen te ontwikkelen
  • Bachelor of Master degree in Bioprocessing, Chemical Engineering, Microbiology of een gerelateerde discipline
  • Vermogen om zelfstandig en in multidisciplinaire teams te werken
  • Bekendheid met Microsoft Office, Teams en relevante bedrijfstoepassingen
  • Kennis van upstream processing operaties
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Volledige omschrijving

The Company: A global healthcare and pharmaceutical organization focused on developing innovative medicines and advanced manufacturing technologies. The organization operates highly regulated production facilities where quality, safety, reliability and continuous improvement are central.

About the Role: We are looking for an Biopharmaceutical Process Engineer to support biopharmaceutical manufacturing operations in Leiden. You will act as an equipment subject matter expert, improving equipment reliability, supporting asset lifecycle management and preventing contamination. The position combines hands on technical engineering, GMP compliance, troubleshooting and continuous improvement within multidisciplinary manufacturing teams.

Responsibilities: Ensure equipment activities and documentation comply with GMP requirements; Lead asset teams and maintain accurate asset information; Identify equipment replacement needs and contribute to the five year asset plan; Support introduction and implementation of new equipment and systems; Perform root cause analysis for equipment failures and recurring inefficiencies; Work with Operations and troubleshooting teams to reduce downtime and production losses; Conduct Gemba walks and assess correct equipment use; Improve equipment safety, quality, reliability, cost and scheduling; Provide expertise in contamination prevention and product integrity; Develop training and promote continuous improvement.

Requirements: Bachelor or Master degree in Bioprocessing, Chemical Engineering, Microbiology or a related discipline; Minimum 3 years of biopharmaceutical processing experience with a Bachelor degree; Minimum 1.5 years of relevant experience with a Master degree; Knowledge of GMP requirements; Knowledge of upstream processing operations; Professional English proficiency at B2 level; Strong equipment troubleshooting and analytical capabilities; Ability to perform root cause analysis and develop practical solutions; Strong stakeholder communication skills; Proactive, organized and accountable working style; Ability to work independently and within multidisciplinary teams; Familiarity with Microsoft Office, Teams and relevant business applications.

Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.

Bekijk bij SIRE Life Sciences B.V. (opent in een nieuw tabblad)

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Biopharmaceutical Process Engineer

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