Validation Specialist for Pharmaceutical Quality Assurance
Vor 5 Tagen
About the Role
We are seeking a highly skilled Qualification and Validation Engineer to join our team in Lucerne, Switzerland.
This position is part of the Validation Unit team and involves supporting Qualification and Cleaning/Sterilization Validation projects. The successful candidate will be responsible for implementing new systems and processes to ensure permanent inspection readiness.
About You
The ideal candidate will have a university degree in Engineering, Biotechnology, Biology, or Microbiology and at least 5 years of experience in a pharmaceutical environment. A good understanding of current GMP regulations and industrial standards is essential.
You should have experience in computer system validation, equipment qualification, and cleaning validation, as well as project management skills and strong communication abilities.
Your Key Responsibilities
- Execute site projects related to Qualification, CSV, and 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
- Develop, review, and improve Qualification and CSV, Cleaning/Sterilization Validation Documentation, such as SOPs and reports
- Support 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
- Implement procedures in agreement with VU Lead and support area's implementation of process changes
- Evaluate innovative equipment / technologies with respect to Qualification, CSV, and Cleaning/Sterilization Validation
- Identify and harmonize practices across the site in relation to Qualification and Cleaning/Sterilization Validation
Requirements
- University degree in Engineering, Biotechnology, Biology, or Microbiology
- At least 5 years of experience in a pharmaceutical environment
- Experience in computer system validation, equipment qualification, and cleaning validation
- Good understanding of current GMP regulations and industrial standards
- Project management skills and strong communication abilities
What We Offer
This challenging role offers the opportunity to work on various projects and develop your expertise in Qualification and Validation. If you are a motivated professional looking to take your career to the next level, we encourage you to apply.
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