- University of Washington (Seattle, WA)
- …Department of Laboratory Medicine and Pathology** has an outstanding opportunity for a ** Computer Systems GxP Validation Specialist** **WORK SCHEDULE** ... manufacture, and distribution. + Maintain an inventory of GxP computer systems , assess validation status, and prioritize actions based on risk.… more
- Bristol Myers Squibb (Indianapolis, IN)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an ... corporate policies and procedures related to all aspects of computer system validation and applicable local processes...and how they relate to existing and new business systems and practices, primarily GxP . + Knowledge… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Specific experience with Veeva Vault products and reporting is a plus + GxP computer systems and validation experience + Knowledge of Quality Systems ... product families, materials, planned and manufactured batches/lots, suppliers/vendors, assets ( computer systems , instruments, equipment), clinical trials, etc.… more
- Insight Global (Emeryville, CA)
- …and validated ( GxP ) systems * Full understanding of Computer System validation methodology. * Experience in requirements definition and analysis ... GxP applications in accordance with established SOPs. * GxP Computer System administration, escalation point, and...point, and maintenance support. * Prepare, review, and approve GxP Computerized Systems Validation lifecycle… more
- Nestle (Brisbane, CA)
- …crucial role in the selection, development, validation , and maintenance of enterprise GxP systems , including Veeva, ServiceNow, Tracelink, Box GxP , SAS, ... primary responsibilities will revolve around supporting IT compliance of GxP systems and processes, partnering with business... Compliance Program. + Partner with QA to manage systems validation , periodic reviews, and vendor coordination.… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**Desired** + Familiarity with regulated systems - general level of understanding of computer systems validation ( GxP ) + Experience as a Enablement ... **_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_** **Essential** + Degree in Computer Science/Business Informatics or other relevant graduate degree required; +… more
- PCI Pharma Services (Bedford, NH)
- …+ Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems from supporting GxP manufacturing and QC operations ... of computerized systems . + Author and review validation documents (IQ/OQ/PQ) supporting GxP computerized ...skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems… 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...compliance to 21 CFR Part 11, Eudralex Annex 11, GxP and applicable FDA/EMA Guidance. + Collaborate with manufacturing,… more
- Capgemini (Nashville, TN)
- …remains accurate, complete, and reliable over its lifecycle. 2.Create and manage the computer system validation strategy and approach, ensuring it aligns with ... _Programmer/Analyst_ **Organization:** _ERD PPL US_ **Title:** _CQR Engineer - Computer System Validation (CSV) Specialist_ **Location:** _TN-Nashville_… more
- Boehringer Ingelheim (Athens, GA)
- …validation project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's ... Master Plan (VMP) and Corporate Policies and Procedures. + Maintains site validation database and document systems , supports feasibility studies, equipment… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …for validation activities including analytical instruments, enterprise and laboratory computer systems validation , facility, utility, systems , ... In this role, you will support the lifecycle of GxP equipment, instruments, computer systems ,...experience in an cGMP/ GxP environment. Familiarity with validation and commissioning is preferred. Familiarity with Computer… more
- ThermoFisher Scientific (Allentown, PA)
- …Validation Engineer, you will collaborate with multiple departments to support the validation of computer systems , equipment, processes, utilities, and ... compliance and timely execution of essential activities to maintain the validation of all GxP systems . **Responsibilities** + Lead and further develop the… more
- Takeda Pharmaceuticals (Columbus, OH)
- …of above activities performed by a vendor, as needed. + Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. + Ensure ... future at Takeda. Join us a Manager, Clinical Data Validation Engineer in our Cambridge, MA office. At Takeda,...compliance with own Learning Curricula, corporate and/or GxP requirements. Performs other duties as assigned within timelines.… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …work effectively within teams. + Capable of adhering to Good Manufacturing Practices ( GxP ) - Compliance, Change Control, Quality Oversight, Validation . + After ... work effectively within teams. + Capable of adhering to Good Manufacturing Practices ( GxP ) - Compliance, Change Control, Quality Oversight, Validation . + After… more
- Bristol Myers Squibb (Devens, MA)
- …facilities, utilities, equipment and analytical instruments commissioning project activities in both GxP and non- GxP systems . This position will interface ... released to system owners for system use (for + non- GxP systems ). + Support multiple projects while...minimum of 1+ years relevant experience with process equipment, computer systems , manufacturing process control systems… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …work effectively within teams. + Capable of adhering to Good Manufacturing Practices ( GxP ) - Compliance, Change Control, Quality Oversight, Validation . + After ... work effectively within teams. + Capable of adhering to Good Manufacturing Practices ( GxP ) - Compliance, Change Control, Quality Oversight, Validation . + After… more
- Merck (Lower Gwynedd, PA)
- …operational and informational technology systems . + Apply deep expertise in the computer system validation process of lab equipment, including the conduct of ... bioanalytical group located at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this...and maintenance to retirement), and manage and improve the computer system validation of laboratory equipment. This… more
- Bristol Myers Squibb (Devens, MA)
- …InfoBatch, Crystal Reports, Spotfire, Tableau, or similar tools. + Understanding of computer system validation . **Education and Experience:** + Bachelor's degree ... requirements and how they relate to existing and new business systems and practices, primarily GxP . + Sound understanding of Electronic Batch Records (EBR) and… more
- Fujifilm (College Station, TX)
- …points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures ... knowledge of engineering principles. + Working knowledge and expertise in computerized systems validation . + Computer System Validation experience with… more
- OnKure, Inc. (Boulder, CO)
- …development phase GMP QA Strong knowledge of GxP regulations, Quality Systems (including Document Control, Training, Change Control, computer system ... support of the Quality Management System (QMS) and is responsible for ensuring GxP and QMS compliance. This position is responsible for ensuring Quality Programs are… more