Qualification, CSV and Cleaning/Sterilization Validation Engineer

• 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 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
  

My Qualifications

• University degree preferable in Engineering, Biotechnology, Biology, Microbiology
• 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

My Benefits

• International reputed Pharmaceutical organisation
• Collaborative team atmosphere
• Training and opportunity to grow and develop in the role

About Hays

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.