- Bristol Myers Squibb (Warren, NJ)
- …or Science related discipline. + Minimum of 5 years of experience in FDA -regulated industry ( validation preferred), or 3 years and an advanced degree. ... The incumbent's focus is support of small to medium size validation projects, such as new product introduction, facilities/utilities upgrade and modification,… more
- Unilever (Englewood Cliffs, NJ)
- …recalls and reworks, POI's (potentially obsolete inventory), end of period reporting, WMS FDA validation , SAP and WMS testing, validating KPI data and assuring ... Sarbanes Oxley compliance. Who You Are & What You'll DoThis position will support projects and serve on cross-functional teams as required. In addition, this position will perform other duties as required such as producing various reports. Further, the… more
- Unilever (Englewood Cliffs, NJ)
- …and guiding Unilever as the face of Microbiology to external regulatory bodies ( FDA , CFIA, etc.) + Micro validation support (formulation advice to ensure ... production processes during product development and innovation, including: - Micro validation support (formulation advice to ensure safety by design; defining… more
- J&J Family of Companies (Raritan, NJ)
- …We are searching for the best talent for a Sr. Engineer, Computer System Validation (CSV) to join our Team **!** Janssen Biotech, Inc., one of the Janssen ... #CAR-T team! The Senior Engineer - CSV is responsible for performing and managing Validation activities, with a focus on computer systems, software, as well as GMP… more
- Integra LifeSciences (Plainsboro, NJ)
- …each essential duty Satisfactorily: + Generation and execution of qualification/ validation protocols including the generation, routing and approval of summary ... sound tests for appropriate support of results. + Complete test method validation , gauge r&r studies and other qualifications or studies to support product… more
- Terumo Medical Corporation (Somerset, NJ)
- …SAP software + Some familiarity with SOX and IRM compliance + Some familiarity with FDA CFR Part 11 Software Validation processes + Keen analytical skills + Keen ... baselines to ensure consistency of + Support SAP COE in testing and validation efforts related to Maintenance Patches, Version Upgrades and integration on New… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles ... and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities… more
- Integra LifeSciences (Princeton, NJ)
- … validation of planning outputs for compliance and accuracy. **Compliance & Validation ** Experience ensuring GxP, FDA , and other regulatory compliance in Life ... for large-scale Medical Device company, ensuring compliance with industry validation procedures & regulations. Possesses a strong understanding of supply… more
- Bristol Myers Squibb (Summit, NJ)
- …at BMS with our Cell Therapy team. The **Lead Computer System Validation (CSV) Engineer** supports the successful implementation of manufacturing and laboratory ... the completion of milestones associated with equipment qualification and systems validation . With minimum supervision and given general instructions, this individual… more
- Sanofi Group (Morristown, NJ)
- …into the appropriate technical language to ensure that configuration, operations, validation , and/or analytic reporting deliverables meet business needs. This role ... in the configuration of the safety database as well as the development, validation and maintenance of the system enhancements including the generation and approval… more