- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team ... documents.Experience with Quality systems (Change control, investigations, LIMs, etc.).Extensive technical writing experience.Knowledge in cell therapy validation … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Support MES validation activities according to the Software Development Lifecycle (eg ... of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing with MES...including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT.… more
- BeOne Medicines (Pennington, NJ)
- …redesigning workflows and implementing solutions like eBR, eLogs, etc.. + Technical Transfer experience including equipment qualification, process validation , ... related to cell culture, purification, filling, packaging and OSD. + Participate and lead in controls fault or process fault analysis and remediation. + Vendor… more
- BeOne Medicines (Pennington, NJ)
- …up activities. + Establish CPV program for process performance + Responsible for technical transfer, validation , investigation, and technical support of ... BeOne's Drug Product Manufacturing site in New Jersey (Hopewell). This role will lead the site drug product MST function to support technology transfer, … more
- System One (Princeton, NJ)
- Lead Validation Specialist Location: Remote (Preference for East Coast candidates) Salary: $125,000-$150,000/year + bonus potential About the Role We're seeking ... an experienced Lead Validation Specialist with a strong background...11 compliance. + Experience with SDLC, Agile methodologies, and validation of cloud-based systems. + Strong technical … more
- General Motors (Trenton, NJ)
- …impactful projects in a dynamic team environment. As the AV Behavior and AI Safety Technical Lead , you will be responsible for working with our partners and ... extensive experience in the full end to end development lifecycle for autonomous vehicle behaviors driven by artificial intelligence...standards and guide the development of GM's AV Behavior Validation and AI safety strategy. This technical … more
- Cognizant (Trenton, NJ)
- **About the role** As an AS400 Technical Lead , you will make an impact by leading the development and delivery of AS400-based solutions in a hybrid ... validating deployments + Assist with regression testing and provide technical support throughout the project lifecycle **Work...regression testing processes + Experience working in a client-facing technical lead role + Ability to mentor… more
- J&J Family of Companies (Raritan, NJ)
- …We are searching for the best talent for a Senior Manager, Technical Services to join our team. This is an onsite position located ... to be part of the #CAR-T team! **Summary:** The Senior Manager, Technical Services, is a leadership role responsible for overseeing the Computerized Maintenance… more
- General Motors (Trenton, NJ)
- …opportunity to lead safety strategy and execution across the entire lifecycle of AV operations, from development and supervised driving to commercial launch and ... years of experience in safety-critical systems engineering, operations safety, or related technical leadership roles. + Proven ability to lead cross-functional… more
- J&J Family of Companies (Titusville, NJ)
- …and features, development standards, release management processes and schedules, testing / validation , and compliance. + Lead analytics capabilities roadmap in ... **Job Function:** Technology Product & Platform Management **Job Sub** **Function:** Technical Product Management **Job Category:** People Leader **All Job Posting… more
- BeOne Medicines (Pennington, NJ)
- …trend process performance, including input and output parameters. + Responsible for technical transfer, validation , investigation, and technical support of ... Transfer and support. based in New Jersey (Hopewell), this role will be to lead the Hopewell drug product MST function to support technology transfer, validation… more
- J&J Family of Companies (Titusville, NJ)
- … lead planning and execution overall data migration including ( Technical Testing, data loads, defect management,by Engineering team; Support business workstream ... **Job Function:** Technology Product & Platform Management **Job Sub** **Function:** Technical Product Management **Job Category:** People Leader **All Job Posting… more
- Cardinal Health (Trenton, NJ)
- …development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical requirements in accordance ... We are seeking a seasoned and experienced Techno Functional Lead to join our high-performing Oracle Agile PLM (Product... to join our high-performing Oracle Agile PLM (Product Lifecycle Management) team. This role is pivotal in bridging… more
- J&J Family of Companies (Raritan, NJ)
- …to define and advance business process models, lead change with positive energy + Lead a team of technical product owners to ensure deep product and process ... Ensure technical and manufacturing requirements are addressed throughout the lifecycle of new solutions + Drive continuous improvement and foster an operational… more
- General Motors (Trenton, NJ)
- …+ Lead the design, development, and implementation of simulation-based validation strategies for autonomous systems, ensuring safety and performance metrics are ... a critical role in leading the strategy and execution of simulation-based validation efforts for autonomous vehicle development. Your expertise will guide a team… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management ... (SME) for downstream processing (chromatography, TFF/UFDF, viral clearance/filtration, etc.). + Lead and manage the technical aspects of downstream process… more
- Ford Motor Company (Trenton, NJ)
- …position We are seeking an experienced and dynamic Embedded Software V&V Manager to lead our ECU Verification and Validation (V&V) team focused on test ... our products meet the highest quality and safety standards. What you'll do + Lead , mentor, and manage a team of Component V&V Engineers focused on automated testing… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …technology transfer activities to new or existing CDMOs. + Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory ... robust and compliant manufacturing processes through effective technology transfer, validation , process monitoring, and lifecycle management. This individual… more
- J&J Family of Companies (Raritan, NJ)
- …the development and management of the HEPA program, including routine inspections, filter validation , and lifecycle management. + Understand and apply Johnson & ... support site operations, including aseptic environments (Grades A-D). + Provide technical support for troubleshooting and resolving HVAC issues across the facility,… more
- J&J Family of Companies (Titusville, NJ)
- …associated business processes for JJIM's Advanced Therapies Supply Chain. Along the lifecycle of our assets, such as facilities, equipment, and utilities, this role ... is the key point of contact for technical matters related to QC Labs mechatronics systems. The...the end user. Support tech transfer activities through process validation and regulatory approval. * Create or support the… more
