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Senior CSV Validation Lead
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Full-time
- We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
- Position Summary:Reporting to the Sr. Dir. Engineering, FM & Validation, the Sr. Computer System Validation (CSV) Lead will collaborate with global and site stakeholders to develop and maintain a robust CSV/data integrity validation program by adopting both global and site level standards and processes.
- Identify improvement opportunities by engaging with stakeholders to ensure processes are optimized and systems are compliant with governing Data Integrity requirements and evolving industry guidance like CSA.Direct the validation process development responsibilities to establish and maintain site level SOPs, Work Instructions, Periodic Reassessment(s), Change Controls and related documents.
- Design, co-create, and co-deliver training that drives System Compliance, Computer Systems Assurance, and traditional CSV.Partner with Engineering & Facilities Management to align/ensure appropriate calibration and/or work order acceptance criteria and frequencies.
- Minimum Qualifications:Hands-on experience with Software Quality Assurance (SQA) methodologies, techniques, approaches, and test automation tools.
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