Qualification and Validation Engineer

vor 1 Tag


Luzern, Schweiz TN Switzerland Vollzeit

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Qualification and Validation Engineer, LucerneJob Reference:

26bc27076527

Job Views:

5

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

Job Description

For our client, a pharmaceutical company based in Lucerne, we are looking for a Qualification and Validation Engineer.

This role is located within the Validation Unit team and supports Qualification and Cleaning/Sterilization Validation projects. It is the responsibility of this function to implement new systems and processes to a state of permanent inspection readiness.


General Information:

  • Start Date: ASAP
  • Duration: 1 year contract
  • Extension: possible
  • Workload: 100%
  • Workplace: Schachen, Luzern

Responsibilities include but are not limited to:

  • Execute site projects related to Qualification, CSV, Cleaning/Sterilization Validation:
    • Support coordination efforts with colleagues across the network to implement best practices and ensure site systems meet all quality and regulatory expectations.
    • Support for the development / review / improvement of Qualification and CSV, Cleaning/Sterilization Validation Documentation: such as SOPs, qualification/validation documents, reports.
    • Support for compliance deliverables and technical deliverables related to qualification and validation.
    • Act as a point of contact deputy for Qualification and Cleaning/Sterilization Validation at the entire Site.
    • Support with Qualification and Cleaning/Sterilization Validation aspects during inspections.
    • Support the implementation of procedures in agreement with VU Lead.
  • Support the area’s implementation of process changes, and root cause investigation of deviations.
  • Support the evaluation of innovative equipment / technologies with respect to Qualification, CSV, Cleaning/Sterilization Validation, reviewing user requirements.
  • Support to identify and harmonize practices across the site in relation to Qualification and Cleaning/Sterilization Validation – simplifying processing to ensure compliance, while decreasing implementation effort.

Your profile:

  • University degree preferable in Engineering, Biotechnology, Biology, Microbiology.
  • Minimum 5 years of experience in pharmaceutical environment with experience in computer system validation, equipment qualification and cleaning validation.
  • Good know-how of current GMP regulations and industrial standards.
  • Experience in Auditing and Compliance within pharmaceutical industry preferred.
  • Change and Deviation Management experience.
  • Project Management skills: organizes work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines, and ensuring on-time delivery. Can define and lead projects to support improvement, implementation or remediation.
  • Strong communication skills: Plans and delivers ideas and information to others in a clear and impactful manner.
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