- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical… 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
- ThermoFisher Scientific (New Brunswick, NJ)
- …GAMP 5, and other applicable global health authority regulations to the lifecycle of computer systems to ensure they are in a validated state, supporting ... system lifecycle activities and 30% management of master systems data. **Key responsibilities:** + Manage and deliver on...Good Testing Practices and solid grasp of cGMPs and Computer System Validations. + Experience with electronic… more
- Lilly (Branchburg, NJ)
- …operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and ... local and corporate policies). + Provide IDS technical and/or validation direction related to computer system...pharmaceutical regulations (eg cGMP's, 21 CFR Part 11, Computers Systems FDA ) and other applicable regulations (eg… more
- Lilly (Branchburg, NJ)
- …software applications for system management, compliance, and data integrity Partners with Computer System Validation (CSV), IT, QC, and QA to ensure ... Assists in the selection, implementation, and maintenance of computerized systems . Authors and reviews computer system...management, testing, and Qualification, Validation of proposed systems + Provide lab management and system … more
- Lilly (Branchburg, NJ)
- …Camstar, or Werum PAS-X). + Minimum 3+ years experience leading or supporting the Computer System Validation of IT platforms including Data Integrity ... and manage multiple tasks simultaneously. * Experience with Computer System Validations. * Experience with Manufacturing Execution Systems and how… more
- Lilly (Branchburg, NJ)
- …operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and ... assessment of all cGXPsystems and dashboards, ensuring that all validation requirements have been met prior to system...pharmaceutical regulations (eg cGMP's, 21 CFR Part 11, Computers Systems FDA ) and other applicable regulations (eg… more
- Roche (Branchburg, NJ)
- …systems . Assists manufacturing operations in problem solving with regards to the automation systems as well as in the validation of process and facility ... an FDA -regulated manufacturing facility. + Responsible for overall control system concept and support. Ability to program, configure, and troubleshoot PLCs, HMI,… more
- System One (Park Ridge, NJ)
- …+ Sterilization & Microbiological Expertise + Lead development, optimization, and validation of sterilization processes including ethylene oxide, dry heat, gamma ... Leadership & Scientific Rigor + Oversee microbiological method development, validation , and data interpretation for regulatory submissions + Manage complex… more
- BeOne Medicines (Pennington, NJ)
- …and release of material, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... late phase activities. + Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards.… more
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