CQV Engineer

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 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.

Qualification:

• 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.