- Bayer (Whippany, NJ)
- …assessment based upon the intended use and configuration of AI. Reviews the testing/ validation of AI. Prepares an AI risk mitigation plan (as needed). Enforce ... medical objectives. Architect : Build robust frameworks for LMR approvals, AI validation , and compliant vendor oversight that sustain excellence. Coach : Enable… more
- Cipla (Fall River, MA)
- …Quality Team. The QA operation specialist (MDI) monitors and ensures validation and qualification of facility, utilities, equipment's, processes and ensure product ... deviation investigation and CAPAs. Review and approval of manufacturing/engineering validation and qualification documents. Provide daily/weekly updates to shop… more
- Cipla (Fall River, MA)
- …to meet GMP by performing surprise checks Prepare and review the qualification, validation and other documents to maintain GMP Participate in the internal and ... preparation and implementation of SOP'S (Case Basis) IT for computerised system validation (Case Basis) Central SCADA Team for Real time process data-Acquisition and… more
- Lundbeck (Bothell, WA)
- …a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new ... product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey to… more
- Stellantis (Detroit, MI)
- …is responsible for retail forecasting, vehicle inventory analysis, reporting, validation , and order allocation. . Supply: This organization aligns demand ... plans with production capacities to develop an optimal vehicle production plan. They are responsible for slotting, scheduling and sequencing orders within our manufacturing facilities as well as order execution, releasing, production programming and capacity… more
- Stellantis (Auburn Hills, MI)
- …Design Release Engineer - Refrigerant Loop is responsible for the development and validation of the automotive HVAC compressor and A/C lines. The candidate will ... ensure the components meet performance objectives and will coordinate development with other functional areas such as powertrain, BIW, Aero/Thermal, Engine Cooling and suppliers. Duties will include (not limited to) writing source packages, specifications,… more
- AUROBINDO (Durham, NC)
- …and chemical testing.Knowledge and experience in method transfer and validation , with prior supervisory roles being advantageous.Familiarity with pharmaceutical ... would be an added advantage Knowledge in Method Development & Method Validation would be preferable and previous supervisory experience would be added advantage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …processes, manage equipment qualification strategy, and support process validation activities for cell therapy platforms.Work cross-functionally across Technical ... and IQ/OQ/PQ testing.Ensure successful manufacturing process comparability and process validation runs by assessing risk, establishing preventative measures, investigating,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with other functions including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT. This individual will ... updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate MES validation activities according to the Software Development Lifecycle (eg commissioning… more
- Cipla (Central Islip, NY)
- …Controls, Technical Deviations, Methods, Specifications, COAs, Batch Records, Validation protocols/reports. Conduct focused time-studies to support packaging ... investigations, Corrective Action Preventive Actions (CAPAs), change controls and validation activities as required. Apply complete knowledge of process improvement… more
