Pharmaceutical Validation Expert
vor 5 Stunden
The role of Qualification and Validation Engineer is to implement new systems and processes to a state of permanent inspection readiness. This involves executing site projects related to Qualification, CSV, Cleaning/Sterilization Validation, and supporting coordination efforts with colleagues across the network to implement best practices and ensure site systems meet all quality and regulatory expectations.
This position requires strong communication skills, project management skills, and the ability to define and lead projects to support improvement, implementation, or remediation. 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 with experience in computer system validation, equipment qualification, and cleaning validation.
Key responsibilities include:
- Execute site projects related to Qualification, CSV, Cleaning/Sterilization Validation
- Support coordination efforts with colleagues across the network
- 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
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