- 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
- NTT DATA North America (Highland Heights, KY)
- …Engineering, or related discipline required. + Master's degree or professional certifications in Computer System Validation (CSV), GAMP 5, or Regulatory ... life cycle documentation including URS, FRS, Risk Assessments, Traceability Matrix, SOPs, and Validation Summary Reports. + Ensure compliance with FDA 21 CFR… more
- Amgen (Thousand Oaks, CA)
- …key IS domains and layers + Understanding of FDA regulations governing computer system validation and operation + Familiarity with security requirements ... and deployment + Develop and maintain System Architecture models (eg System Interaction diagrams) and reference implementations within systems of record (eg… more
- Bausch + Lomb (Tampa, FL)
- …elements: manufacturing/ packaging equipment, facilities, utilities, computerized systems , temperature-controlled areas/equipment, Media Fills, and sterilization ... the company and is consistent with the company's policies and practices. + Ensure that validation activities meet the requirements of FDA (21 CFR 820 and 21 CFR… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance** **Position Summary:** Catalent, Inc. is a leading global ... Specialist is primarily responsible for leading, implementing and managing Computer System Validation (CSV) and...and Regulatory Compliance. Familiarity with cGMPs, ISPE GAMP5, fundamental validation practices and the following FDA and… more
- Cognizant (Boston, MA)
- …or life sciences domain, including 2+ years in a management role. + Expertise in Computer System Validation (CSV) and Computer Software Assurance (CSA). ... Lead** , you will make an impact by leading validation and testing initiatives across life sciences systems...this role, you will:** + Develop and implement comprehensive validation and test strategies aligned with FDA ,… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other ... as needed to support the Specialty Generics organization. Software systems may be local or hosted solutions. The candidate...at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation … more