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Validation Engineer (DE)
[16514]
Validation, GMP, Aseptisch
We are seeking a proactive and detail-oriented Validation Specialist to support the commissioning and qualification of a new aseptic manufacturing area. This role is critical in ensuring compliance with GMP standards through robust validation activities, including cleaning and sterilization processes. Project title: Validation Engineer Type of employment: Payroll Industry: Biotech Skills: Validation,GMP,Aseptisch Project start: 01/09/2025 Project duration: 30/11/2025 Location: Neuchâtel, Switzerland Tasks: ·Review SAT (Site Acceptance Test) execution protocols ·Prepare IOQ (Installation and Operational Qualification) reports using a leverage approach ·Author and execute cleaning validation protocols ·Perform rinse water and surface sampling ·Compile and finalize validation reports ·Author and execute sterilization validation protocols ·Set up thermocouples using the Kaye system ·Place bioindicators and document results ·Compile and finalize validation reports ·Utilize Kneat for protocol management, execution, and reporting Qualifications: ·5+ years of experience in validation activities within aseptic or GMP-regulated environments ·Familiarity with cleaning and sterilization validation techniques ·Hands-on experience with thermocouple systems (e.g., Kaye) and bioindicator placement ·Proficiency in digital validation platforms (preferably Kneat) ·Strong attention to detail and documentation accuracy ·Flexible, collaborative, and a strong team player ·French language knowlegde
We are seeking a proactive and detail-oriented Validation Specialist to support the commissioning and qualification of a new aseptic manufacturing area. This role is critical in ensuring compliance with GMP standards through robust validation activities, including cleaning and sterilization processes.
Project title: Validation Engineer
Type of employment: Payroll
Industry: Biotech
Skills: Validation,GMP,Aseptisch
Project start: 01/09/2025
Project duration: 30/11/2025
Location: Neuchâtel, Switzerland
Tasks:
- Review SAT (Site Acceptance Test) execution protocols
- Prepare IOQ (Installation and Operational Qualification) reports using a leverage approach
- Author and execute cleaning validation protocols
- Perform rinse water and surface sampling
- Compile and finalize validation reports
- Author and execute sterilization validation protocols
- Set up thermocouples using the Kaye system
- Place bioindicators and document results
- Compile and finalize validation reports
- Utilize Kneat for protocol management, execution, and reporting
Qualifications:
- 5+ years of experience in validation activities within aseptic or GMP-regulated environments
- Familiarity with cleaning and sterilization validation techniques
- Hands-on experience with thermocouple systems (e.g., Kaye) and bioindicator placement
- Proficiency in digital validation platforms (preferably Kneat)
- Strong attention to detail and documentation accuracy
- Flexible, collaborative, and a strong team player
- French language knowlegde
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