- Cordis (Irvine, CA)
- …implement practical business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation ... (PLM). You'll map business processes end-to-end, translate them into system requirements, and lead continuous improvement initiatives that boost productivity,… more
- Reynolds American (Winston Salem, NC)
- …+ Experience supporting Product, R&D, and regulatory business teams, with understanding of FDA Computer System Validation requirements and validated ... and resourcing requirements. **What are we looking for?** + Bachelor's degree in Computer Science, IT, Software Engineering, or related field; Master's degree in … more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who...In depth understanding and knowledge of successfully validating a computer system to meet all FDA ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
- Bristol Myers Squibb (Devens, MA)
- …. **Summary:** We are seeking a highly skilled and motivated Senior Engineer - IT Computer System Validation (CSV) to join our team at the Devens ... accordingly. + High quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical computerized systems field and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part… more
- Bristol Myers Squibb (Summit, NJ)
- …Qualification of equipment and full CSV for single and multi-user Computerized Systems . + Develops validation /qualification deliverables such as Validation ... implementation and support of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and… more
- Sanofi Group (Swiftwater, PA)
- …Swiftwater site, supporting directly the manufacturing system automation computer system validation . As a Computerized Systems Validation ... possible. Ready to get started? **Main Responsibilities:** + The Computer System Validation Engineer will...in computerized systems . + Expertise in OT system validation processes and lifecycle. + Knowledge… more
- Jabil (Hunt Valley, MD)
- …the validation teams. + Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise CSV associates. Ensure ... activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory… more
- NTT DATA North America (Highland Heights, KY)
- …Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, or related discipline. Preferred certifications: Computer System Validation (CSV), GAMP 5 ... sequencers, PCR systems ). Equipment qualification (DQ, IQ, OQ, PQ) and computerized system validation . Regulatory compliance with FDA 21 CFR Part 11,… more
- Bristol Myers Squibb (Devens, MA)
- …systems and manufacturing execution system recipes, computer systems , and laboratory instrumentation. + Implement validation philosophies and master ... regulatory inspection readiness. Work collaboratively with peers within the Validation Execution function, Manufacturing Systems , Information Technology,… more