Senior Quality Engineer
Bekijk en reageer bij SIRE Life Sciences B.V. (externe link)
Senior Quality Engineer voor kwaliteitsoverzicht van MES en CSV bij een biotechbedrijf in Hoofddorp, Noord-Holland.
- Locatie
- Hoofddorp
- Werkvorm
- op locatie
- Uren
- 40 uur per week
- Contractvorm
- detachering
- Startdatum
- Eerste waarneming
- Opdrachtgever
- Global leader in advanced cell therapy
Eisen
- Bachelor's or Master's degree in Engineering, Life Sciences, Quality, or a related technical field
- Strong knowledge of validation lifecycle (IQ/OQ/PQ), change control, deviations, and quality systems
- Proven experience in Computer System Validation (CSV), MES validation, and GMP/GxP regulated environments
- Hands-on experience with Werum PAS-X MES
Wensen
- Experience with risk management tools such as FMEA/HACCP and continuous improvement methodologies (Six Sigma/DMAIC)
Omschrijving
The client is a global leader in advanced cell therapy, specializing in developing and delivering cutting-edge treatments for patients with serious illnesses. The organization operates state-of-the-art manufacturing facilities and follows the highest GMP standards to ensure quality and safety. As a Senior Quality Engineer, you will be responsible for providing quality oversight for MES and Computer System Validation (CSV) projects, ensuring compliance with GMP and regulatory requirements. You will review and approve validation deliverables, support Werum PAS-X validation activities, and drive continuous improvement initiatives within a pharmaceutical manufacturing environment. Responsibilities include: providing Quality oversight for MES and CSV projects, ensuring compliance with GMP and regulatory standards; reviewing, approving, and maintaining CSV validation deliverables, including initial validation, change control, and periodic revalidation activities; supporting Werum PAS-X MES qualification and validation activities; collaborating with cross-functional teams to implement process improvements, quality initiatives, and risk management strategies; supporting CQV activities, quality risk assessments, audits, and continuous compliance improvement programs. Requirements: Bachelor's or Master's degree in Engineering, Life Sciences, Quality, or a related technical field; proven experience in Computer System Validation (CSV), MES validation, and GMP/GxP regulated environments; hands-on experience with Werum PAS-X MES is required; strong knowledge of validation lifecycle (IQ/OQ/PQ), change control, deviations, and quality systems; experience with risk management tools such as FMEA/HACCP and continuous improvement methodologies (Six Sigma/DMAIC) is preferred. Start date: 8 July 2026, Hoofddorp, Noord-Holland. Job ref: 58655.
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