CQV Engineer m​/w​/d

The CQV Engineer is a role within the Validation Unit team. 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 ensures 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.

CQV Engineer

asap

12 months

• 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.

• 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.