Qualification and Validation Engineer.

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 in 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.