- 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
- Kedrion Biopharma (Melville, NY)
- …automation and computer systems within a GMP production facility. Computer System Validation Specialist is responsible for managing, developing, and ... hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Computer System Validation Specialist at...portfolio. This position will lead management of validation lifecycle for computerized systems . The CSV… 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
- Regeneron Pharmaceuticals (Troy, NY)
- …the following: + Develop and maintain an industry leading approach to computer systems validation . + Lead the development of processes and systems ... that drive compliance to critical regulatory requirements specific to IT systems , including enterprise systems . + Responsible for leading and maintaining a… 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 (Allen Park, MI)
- …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
- United Therapeutics (Silver Spring, MD)
- …to apply your expertise in a dynamic biotech and pharmaceutical environment? As a Lead Validation Engineer, Equipment, you'll be a subject matter expert in ... a fast-paced, highly regulated environment. This role offers the opportunity to lead complex validation projects, troubleshoot unique challenges, and collaborate… 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
- Novo Nordisk (Bloomington, IN)
- … validation + Understand other validation technical disciplines, such as cleaning, computer system validation , and process validation , and be able ... and help us make what matters. Position Responsible to lead validation strategy and mentor engineers/senior engineers...other validation technical disciplines, such as equipment validation , computer system validation… more
- NVIDIA (Santa Clara, CA)
- We are seeking Lead Post-Silicon Validation Engineer within the GPU Engineering Team to help drive development of future GPUs be used in 3D graphics, deep ... 1999 fueled the growth of the PC gaming market, redefined modern computer graphics, and revolutionized parallel computing. More recently, GPU deep learning ignited… more
- General Motors (Little Rock, AR)
- …that location three times a week, at minimum. **Role Overview:** As a Technical Lead within the Validation , Tools, Acceleration (VTA) team under the Simulation, ... strategy to ensure alignment with broader company objectives, designing and implementing systems to support AV / ADAS development. You will drive software… more
- BioBridge Global (San Antonio, TX)
- …agencies or clients. Train staff on validation protocols. Manage incoming validation tickets via the ticketing system to ensure validations are assigned ... Must be familiar with the equipment maintenance system , environmental monitoring system , and ticket management systems . Must be familiar with pulling reports… more
- Catalent Pharma Solutions (Harmans, MD)
- …and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation , USP Guidelines, ICH Guidelines, and ISPE GAMP ... Part 11, Eudralex Annex 11, and electronic data integrity requirements. + Lead validation and engineering projects, including IQ/OQ/PQ execution for bioreactors,… more
- Meta (Sunnyvale, CA)
- …-related occupation. 10. Requires three years of experience in the following: 11. 1. Lead system validation by developing and executing comprehensive test ... The Product Validation Engineer focuses on end-to-end systems validation from new product introduction, new...Responsible for managing and driving execution of EE and system level validation of products under development.… more
- Takeda Pharmaceuticals (Libertyville, IL)
- …focus on disciplines related to equipment, cleaning, process, control system and computer system validation . **How you will contribute:** + Experience ... Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation , and Validation… more
- Novo Nordisk (Clayton, NC)
- …and help us make what matters. The Position Primary responsibility is to provide/ lead validation services required for the successful delivery of highly ... source of expertise in the group for validating new systems + Ensure compliance of validation protocols...are aligned with local, corporate & regulatory regulations + Lead validation failure investigations & non-conformities utilizing… more
- AbbVie (North Chicago, IL)
- …of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (eg Computer , Equipment, Cleaning, Process, etc.) preferred ... Tok (https://www.tiktok.com/@abbvie) . Job Description The primary responsibility for the Validation Specialist is the planning and overall approval of validation… more
- Cook Medical (Pittsburgh, PA)
- …protocols, SOPs, and final reports), and protocol execution.* Plan, author, and lead validation of instruments and assays.* Oversee/manage execution of assay ... qualified instruments.* Prepare turn over packages (TOP) to transfer systems in a validated state to system ...in Quality Control * Robust understanding of cGMP and validation systems and processes; experience with USP… more
- ThermoFisher Scientific (Santa Clara, CA)
- …and implement comprehensive validation plans, protocols, and reports for Bioprocess systems . + Lead product validation activities, including Installation ... principles, methodologies, and regulatory requirements. + Strong background in completing validation protocols for complex systems . + Extensive experience in… more
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