- University of Washington (Seattle, WA)
- …The 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
- 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
- BeiGene (Hopewell, NJ)
- … Strong + Experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). + Previous experience ... **_General_** **_Description:_** This position will provide leadership and support for IT Systems that enable the BeiGene Hopewell US Site Quality functions. They… more
- Randstad US (Cambridge, MA)
- …MUST HAVE + MUST have GxP and or CFR 21 Part 11 and systems validation . + Life Sciences, Biotech or pharmaceutical industry experience + An understanding of ... per hour + contract + bachelor degree + category computer and mathematical occupations + reference1064491 job details job...with GxP , CFR 21 Part 11 and systems validation . - Life Sciences, Biotech or… more
- BeiGene (Hopewell, NJ)
- …+ Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). + Previous ... iPads, and iPhones. + Build, configure, repair, and maintain new and existing computer systems and peripherals. + Develop and review technical documentation. +… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … validation or qualification of global GxP and Non- GxP computer systems .Create and review various validation documentation such as Validation ... **Responsibilities** - Provide Validation Lead support for Daiichi Sankyo GxP and Non- GxP computer systems implementations in partnership with Global… more
- Carrier (Beverly, MA)
- …day. Join us and we can make a difference together. **About this role** As a Computer Systems Validation Lead, you will lead and manage the Validation ... Program for Sensitech systems and products. The Validation Lead will work with the Sales, Product, Engineering,...validation program. + Stay current on the latest GxP regulations and industry best practices for Computer… more
- Amgen (West Greenwich, RI)
- …work alongside other innovative, driven professionals in this meaningful role. **Specialist Computer Systems Validation Engineer** **Live** **What you will ... lead with business and DTI partners for process and computer systems analysis, requirements elicitation, articulating system... GxP and SOX compliance requirements + Lead computer validation testing initiates with oversight of… more
- Kelly Services (Wilmington, DE)
- **Kelly Services is actively recruiting for a Computer Systems Validation Specialist for a Long Term Contract opportunity in Newark, DE.** Qualifications: ... The official position title is Computer System Validation (CSV) specialist to support...(CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems .… more
- Actalent (Bothell, WA)
- Computer System Validation Engineer + The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation ... Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications...validation periodic reviews, audit activities, and support of computer system validation efforts for new system… more
- J&J Family of Companies (Columbus, OH)
- …support at Abiomed. + Develop and execute validation plans for new and existing GxP computer systems and digital solutions. + Support Validation ... Staff Computer System Validation (CSV) Engineer -...CSV Engineer will be responsible for ensuring that all computer systems and software applications used within… more
- Eurofins (Columbia, MO)
- …to join our Quality Systems team located in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation ... writing, reviewing / approving CSV lifecycle documents such as Validation Plans, GxP Assessments, Traceability Matrices, Risk...and remain expert on the regulatory requirements pertaining to computer systems used in the manufacture and… more
- Eurofins (Columbia, MO)
- …to join our Quality Systems team located in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation ... writing, reviewing / approving CSV lifecycle documents such as Validation Plans, GxP Assessments, Traceability Matrices, Risk...and remain expert on the regulatory requirements pertaining to computer systems used in the manufacture and… more
- Bristol Myers Squibb (Bothell, WA)
- …Expert knowledge of cGMP, GDP, GXP , GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and data ... and system with validation document deliverable in respect to cGMP, GDP, GXP , GAMP5 regulations, including 21CFR Part 11, computer system validation … more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …QA Validation Engineer to represent St. Louis when globally deployed computer systems are implemented. Primary Responsibilities: + Participate in projects as ... meetings and advise cross functional team members for planning validation , change management and decommissioning of NPSW systems...Represent the needs of the site for globally deployed computer systems . + Reasonable, reliable attendance and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …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
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- Job Title Analytical Method Validation Specialist Requisition JR000014442 Analytical Method Validation Specialist (Open) Location St. Louis, MO Additional ... Locations Job Description Summary The analytical method validation review specialist is responsible for conducing comprehensive reviews of analytical methods to… more
- ThermoFisher Scientific (Summit, NJ)
- …change control process. + Advance knowledge of pharmaceutical, laboratory and manufacturing systems and equipment + Highly proficient computer skills in ... relationship with all the members of the GMP Laboratory Systems and site customers while promoting a positive team...Skills and Abilities:** + Experience and understanding of cGMP, GXP , GDP, SDLC regulations, including 21 CFR Part 11… more
- Insight Global (Edison, NJ)
- …(application development and support) SDLC/ITIL (incident/priority/resolution) - Familiar with GxP systems , Computer System Validation and in the support ... the day with reliability, review on incidents open (which systems need to be connected internally) - follow up...in Process Mapping and Design preferred. Experience in MLL systems such as, MES, LIMS, Historian, Lab Systems… more