- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization. ... This position ensures that all global systems , electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry… more
- BioAgilytix (Durham, NC)
- …processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement ... for centralized data storage.Create APIs to enable real-time data sharing between systems , with a focus on operational efficiency and data integrity. Data Quality… more
- Merck & Co. (Rahway, NJ)
- …Qualification and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary ... on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations...reports.- Execute qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation … more
- Twist BioScience (South San Francisco, CA)
- …11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ ... are seeking an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic...DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and… more
- 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 (Indianapolis, IN)
- …to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing ... and commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT… more
- Cognizant (Muskegon, MI)
- …10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist Client ... Historian, MES, ABB as well as other DCS and OT systems . **Requirements** : The Validation Lead responsibilities include: Project master validation … more
- Boehringer Ingelheim (St. Joseph, MO)
- …Specialist, CSVC oversees all aspects of computer system and computer system and computerized equipment validation within BIAH Operations, including ... moderate to complex projects. + Thorough understanding of computerized system validation requirements for GxP systems...vaccine regulated articles. + Demonstrated ability to work and lead in a team environment. + Attention to detail… more
- Lilly (Pleasant Prairie, WI)
- …objectives and initiatives. **Key Objectives/Deliverables** + Lead and perform computer system validation projects for manufacturing and laboratory ... Data Leader and Site Tech@Lilly leadership to implement the computer system validation (CSV) and...instruments and systems . + Ensure that site Computer System Inventory list is maintained and… more
- Abeona (Cleveland, OH)
- Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... production. Essential Duties and Responsibilities . Develop and execute validation deliverables for new and existing GxP systems...and Design Specifications, Test Plans, and Summary Reports. . Lead CSV efforts for systems supporting biotech… more
- Bristol Myers Squibb (Summit, NJ)
- …there's no better place than here at BMS with our Cell Therapy team. The ** Lead Computer System Validation (CSV) Engineer** supports the successful ... to the completion of milestones associated with equipment qualification and systems validation . With minimum supervision and given general instructions,… more
- Kedrion Biopharma (Melville, NY)
- …and laboratory environments. As a Subject Matter Expert (SME), you will lead validation efforts and support the development, commercialization, and lifecycle ... audit trails, access controls, data migration, and backup._ + _Own and maintain system validation procedures and documentation across the site._ + _Partner with… more
- Cognizant (Auburn Hills, MI)
- …Vehicle Triage, SWAT and Launch Support, etc. **What you'll be doing:** The Senior Lead Validation Engineer is responsible to lead electrical feature ... We are looking for talented engineers with backgrounds in Electrical and Computer Engineering for such roles as Vehicle Systems Engineering, Electrical… more
- CGI Technologies and Solutions, Inc. (New Brunswick, NJ)
- …is acceptable. **Your future duties and responsibilities:** * Lead and execute computer system validation (CSV) activities for lab instruments, software, ... and experienced Lab System Validation Analyst to support validation efforts for computerized laboratory systems in regulated (GxP) environments. This… more
- Catalent Pharma Solutions (Harmans, MD)
- …This position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the ... ** Lead Specialist, QA Validation & Engineering**...completion in a Quality role. + Support the Computerized System Validation Lifecycle to ensure compliance to… more
- Ford Motor Company (Long Beach, CA)
- …Low Voltage systems and be responsible for ensuring reliable performance. You will lead system -level design and validation activities and work side by ... definition, prototype bring-up, and validation with a system level focus. You will lead bring-up...What you'll do + Design and develop low voltage systems based on system requirements + Develop… more
- NVIDIA (Santa Clara, CA)
- …for a Senior Hardware Validation Engineer to lead hardware validation activities in the Datacenter Systems Engineering team. You'll work closely with ... solution architects, HW system engineers, validation engineers, OEM/ODMs, and AE...Strong understanding of digital design, circuit design and analysis, computer architecture and CPU/GPU architecture. + Validation … more
- Northrop Grumman (Annapolis Junction, MD)
- …**Preferred Qualifications for Staff Systems Engineer - Verification and Validation :** + Advanced Degrees in Electrical Engineering, Computer Engineering, ... are seeking a candidate for the position of **Staff Systems Engineer - Verification and Validation (V&V)**...I&T program will adequately confirm requirement compliance + Design validation approaches to ensure the system fulfills… more
- NVIDIA (Santa Clara, CA)
- … bring-up activities and characterization of high-speed mixed signal circuits and will lead system validation with electro-optical transceivers. The ideal ... 1999 sparked the growth of the PC gaming market, redefined modern computer graphics, and revolutionized parallel computing. More recently, GPU deep learning ignited… more
- Cisco (San Jose, CA)
- AI Software Engineering Tech Lead (AI Validation / AI Artifacts) Apply (https://jobs.cisco.com/jobs/Login?projectId=1444951) + Location:San Jose, California, US ... and innovative group of experts dedicated to safeguarding AI systems and ensuring their safety, integrity, and robustness. We...industry, and for a better world. **Your Impact** + Lead the design, development, and evolution of our AI… more
