Title: CSV Lead/Project Manager

Location: Columbus, OH

Duration: 12+ Months

Requirements:

1. Minimum 8 years of experience in the field of validation working on qualification activities of various systems
2. Be able to develop and implement validation strategies, plans, and protocols for various systems, processes, or equipment within the organization.
3. Be able to lead and manage a team of validation professionals to execute validation activities effectively and efficiently.
4. Be able to review validation documentation, including validation plans, protocols, test scripts, reports and deviations
5. Be able to support the leverage of documentation from FAT, SAT and review system level impact assessment
6. Be able to collaborate with cross-functional teams, such as quality assurance, regulatory affairs, engineering, and production, to ensure alignment and coordination of validation activities
7. Be able to provide guidance and support to project teams and stakeholders regarding validation requirements, best practices, and compliance issues
8. Be able to Oversee the execution of validation activities, including performing or coordinating equipment qualification and other related activities
9. Be able to track validation progress, ensuring timely completion of validation activities within the defined timelines
10. Be well versed with WFI system qualification
11. Should have the ability to prioritize tasks, manage timelines and coordinate resources effectively
12. Knowledge on performing validation activities using KNEAT
13. Be able to generate and complete all validation related investigations using root cause analysis
14. Be able to review and drive closeout of actions on QMS.