- 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.).Coordinate MES validation activities according to the Software Development Lifecycle (eg ... Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support to… 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
- 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
- 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
- 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
- J&J Family of Companies (Titusville, NJ)
- …contact for all technical matters related to Commissioning, Qualification & Validation . The CAR-T (CQV) Lead is responsible for providing compliance ... site level and beyond, with a focus on Commissioning, Qualification, Re-qualification, and Validation within the JJIM CAR-T facilities. The Lead will provide… 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
- 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
- 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
- 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
- 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
- J&J Family of Companies (Raritan, NJ)
- …inspectors from regulatory agencies on matters related to IT processes, computer system validation , and other technical topics and assist/accompany technical ... Responsibilities include portfolio and program management for TRC Compliance Programs; lifecycle management of TRC functional systems and deployment of new digital… 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 cell processing systems. The CAR-T...the end user. Support tech transfer activities through process validation and regulatory approval. * Create or support the… 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
- 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 cell processing mechatronics systems. The...the end user. Support tech transfer activities through process validation and regulatory approval. * Create or support the… 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 a key point of contact for technical matters. The Senior Manager Maintenance & Utilities is...the end user. Support tech transfer activities through process validation and regulatory approval. + Ownership for clean utility… more
- J&J Family of Companies (Titusville, NJ)
- …Senior Manager CAR-T Execution (Automation) Systems is responsible for providing technical expertise, using standard methodologies, and developing internal as well ... and laboratory execution systems meet operational requirements. You will lead and drive systems through Engineering, Procurement, and Construction Phases… more
