Qualification & Validation Engineer

vor 3 Wochen

Luzern, Schweiz Randstad Vollzeit
For our client, a pharmaceutical company based in Lucerne, we are looking for a motivated Qualification & Validation Engineer.

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

The person will ensure the success of the unit by maintaining a strategic focus and a high customer service level, fostering a high-performance organization, and effectively collaborating across the organization. The position ensures a culture of self-direction, empowerment, and accountability, while providing the support necessary to team members working in a widely cross-functional organization.

General Information:
 
  • Start date: ASAP
  • Duration: 1 year
  • Extension: very likely
  • Workplace: Lucerne
  • Workload: 100%
  • Home office: 1-2 days per week possible

    The Primary Responsibilities include but are not limited to the following:
     
    • Executes 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 WAG Site.
        • Support with Qualification and Cleaning/Sterilization Validation aspects during inspections.
        • Support the implementation of procedures in agreement with VU Lead.
        • Support the areaâs 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 â 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.
          • Fluent English and basic German skills

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