- Fujifilm (College Station, TX)
- … Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems , engineering design ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …of GMP Quality Assurance, with specific experience in quality engineering, validation , computer system validation , quality technical ... related to data integrity. + In collaboration with site Quality ensure that all data systems and...Assurance, with specific experience in quality engineering, validation , computer system validation… more
- Lilly (Durham, NC)
- …+ At least 1 year of relevant work experience in information technology, engineering, computer system validation , quality control support or related ... first and quality always". **Responsibilities:** This Tech@Lilly Quality Control & Quality Assurance Systems...(ie Veeva QualityDocs, Tulip, etc.) + Solid knowledge of Computer System Validation process +… more
- TEKsystems (Green Valley, AZ)
- …as autonomy Skills Validation , Automation, root cause analysis, Computer system validation , software testing, Quality assurance testing, Design ... Software validation Top Skills Details Validation ,Automation,root cause analysis, Computer system validation ,software testing, Quality assurance… more
- Lilly (Indianapolis, IN)
- …assistance and mentorship in the execution of change controls, equipment qualification, process validation , computer system quality , deviations, and ... position provides quality oversight of the Production Quality System in support of operations, including...+ Knowledge of cGMPs, Production Processes, Quality Systems , and FDA regulations + Experience supporting computer… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …qualification and validation activities. + Review and approve computer system related validation documents and quality system records ... daily maintenance, account management, troubleshooting and training. Additionally, you will provide quality support relative to computer systems on site,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …environment (with minimum of 5 years)with focus on quality assurance and/or computer system validation . + Strong written and oral communication skills, ... and technical risks Proactive and consultative engagement of the Computer System Validation role within...and/or Engineering + Excellent knowledge of international GMP requirements, Quality systems , Quality management (EU-GMP… more
- Bristol Myers Squibb (Devens, MA)
- …more: careers.bms.com/working-with-us . **Summary:** We are seeking a highly skilled and motivated Computer System Validation (CSV) Engineer to join our team ... best practices. + Stay current with industry trends and regulatory updates related to computer system validation . **Qualifications:** + Bachelor's degree in … more
- PCI Pharma Services (Bedford, NH)
- …and guidelines (eg FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or Pharmaceutical ... with departments inside the organization to maintain and improve computer system validation processes to...skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... involved in processing steps related to equipment, facility/utility and computer systems validation . This role...to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE… more
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... and commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT… more
- Lilly (Indianapolis, IN)
- …ingredients (API) and parenteral manufacturing for future injectable therapies (Drug Product). The Computer System Validation Engineer is an Engineering role ... Automation & Control Engineering team (GPACE). It will support Computer System Validation and Data... practices, industry/regulatory knowledge in Data Integrity, and Lilly Quality Systems . The role will focus on… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part… more
- Novo Nordisk (Petersburg, VA)
- …and help us make what matters. The Position Plan, manage & performing laboratory validation activities on computer software systems . This role will also ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...Experience in managing projects preferred + Experience with electronic validation systems (TIMS) and SAP PM and… more
- Cognizant (Muskegon, MI)
- …Lead, and Project Manager. + Perform initial Computer System Validation (CSV) at client sites for systems including DeltaV, Historian, MES, ABB, ... ** Computer System Validation Engineer...scalable, enterprise applications. Our Developers have a passion for high- quality , reliable, and maintainable code. You will work side… more
- CACI International (Houston, TX)
- NASA Lunar Gateway Autonomous Control System Verification and Validation (V&V) Software Systems Engineer Job Category: Engineering Time Type: Full time ... Program at NASA Johnson Space Center, for an early to mid-career **Software Systems Engineer** to perform integrated Verification and Validation (V&V) of the… more
- System One (Bellevue, WA)
- …experience in nuclear safety software verification and validation activities and system transient analysis computer code benchmark. * Familiarity with EMDAP ... Accident (DBA) Without Radionuclide Release * Nuclear safety analysis computer code assessment, verification and validation The...get work done more efficiently and economically, without compromising quality . System One not only serves as… more
- Curia (Rensselaer, NY)
- …protocols and master plans, supervises validation activities such process/ equipment/ cleaning/ computer system validation etc. + Review and approve lab ... to provide quality review and approval of validation activities associated with changes to existing systems...+ Provide technical assistance and training for personnel on validation activities + Execute Quality System… more
- Google (Madison, WI)
- …system schedules and achieve readiness for production in various silicon and system validation environments. Serve as a bridge between specification, design, ... contribute to cross-functional work streams focused on Hardware/Software(HW/SW) integration and validation to demonstrate HW, SW, and system functionality and… more
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