- BeiGene (Hopewell, NJ)
- … Strong + Experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation ( CSV ). + Previous experience in ... **_General_** **_Description:_** This position will provide leadership and support for IT Systems that enable the BeiGene Hopewell US Site Quality functions. They… more
- Lilly (Indianapolis, IN)
- …Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation ( CSV ). + Proven ability to ... data including data released from CM (Contract Manufacturers), stability, process validation , and reference standard characterization. + Utilizes technical skills to… more
- Lilly (Indianapolis, IN)
- …and facilitate remediation efforts. + Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems Validation ( CSV ) of GMP assets ... in a cGMP facility + Prior experience in C&Q, CSQ, and/or CSV + Proficient with computer systems including Microsoft Office, electronic document management … more
- BeiGene (Hopewell, NJ)
- …+ Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation ( CSV ). + Previous experience in ... iPads, and iPhones. + Build, configure, repair, and maintain new and existing computer systems and peripherals. + Develop and review technical documentation. +… more
- J&J Family of Companies (Columbus, OH)
- Staff Computer System Validation ( CSV ) Engineer... validation plans for new and existing GxP computer systems and digital solutions. + Support ... Johnson & Johnson Abiomed is recruiting for a **Staff Computer System Validation ( CSV ) Engineer.**... Engineer will be responsible for ensuring that all computer systems and software applications used within… more
- ThermoFisher Scientific (Frederick, MD)
- …in highly regulated environments; knowledge of Good Manufacturing Practices (GMP or GxP) and Computer Systems Validation ( CSV ) is required. + Strong ... clear. **Minimum Requirements/Qualifications:** + Bachelor's Degree in Information Technology, Computer Science, Generative AI, Information Security, or a related… more
- Curia (Albuquerque, NM)
- Senior CSV Systems Engineer in Albuquerque, NM...experience working in a cGMP regulated industry specific to computer systems validation + ... services to the pharmaceutical and biotechnology industries. The Senior CSV Systems Engineer is an integral part...This position will be responsible for supporting Quality Management Systems and Computer System Validation … more
- Avispa Technology (Hillsboro, OR)
- Computer System CSV Support Specialist ROCGJP00027575 A leading biotechnology company is looking for a Computer System Support Specialist to work at their ... highly automated pharmaceutical drug substance facility, which employs highly integrated computer control systems to manage plant operations and manufacturing… more
- Verista (New Brunswick, NJ)
- …+ Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/ systems / software, and processes ... + Conduct risk assessments and implement mitigation strategies for computerized systems . + Oversee documentation lifecycle for CSV activities, ensuring… more
- Verista (Boston, MA)
- …Qualifications Protocols, Trace Matrices and Summary Reports associated with validated computer systems + Engage in Quality process improvement initiatives, ... our collective expertise Senior CSV Engineer/Analyst Responsibilities: + Provide IT CSV support to implement and validate electronic systems in accordance… more
- Mentor Technical Group (Carolina, PR)
- … Summary Report). + Working knowledge of the development of protocols for the Validation of complex computer systems (eg, multiple GAMP classes of ... in Project execution within at least one area of systems validation - eg, laboratory equipment, facilities...5 plus years of experience in the field of computer validation . Mentor Technical Group es un… 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,...expectations. **Key Responsibilities:** + Define and maintain a global Computer System Validation ( CSV ) methodology… more
- Catalent Pharma Solutions (Chelsea, MA)
- …its kind for DPI in North America. Catalent Pharma Solutions is hiring a Computer System Validation ( CSV )/ Qualification Engineer is responsible for ... managing, developing, and implementing the Computer System Validation program and equipment qualification...compliance (world CSV regulations); + Familiarity with computer infrastructure, servers, workstations, Operating Systems , and… more
- PCI Pharma Services (Bedford, NH)
- …and database management skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems /software/equipment supporting GMP ... CSV Validation Engineer II shall support CSV team in maintaining the systems /software in... validation (IQ, OQ, and PQ) documentation for computer /computerized systems from supporting GxP manufacturing and… more
- University of Washington (Seattle, WA)
- …Department of Laboratory Medicine and Pathology has an outstanding opportunity for a ** Computer Systems GxP Validation Specialist** **WORK SCHEDULE** + 40 ... IT, business leadership, and stakeholders, focusing on computerized system validation ( CSV ) in a GxP regulated environment....manufacture, and distribution. + Maintain an inventory of GxP computer systems , assess validation status,… 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...) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems .… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. **Summary** Manage Global DX Computer System Validation ( CSV ) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and ... computer system validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation documentation such as … 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 ... Responsible for providing guidance and writing, reviewing / approving CSV lifecycle documents such as Validation Plans,...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 ... Responsible for providing guidance and writing, reviewing / approving CSV lifecycle documents such as Validation Plans,...and remain expert on the regulatory requirements pertaining to computer systems used in the manufacture and… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …of validation standards as they apply to facilities, utilities, equipment, computer systems , cleaning and processes. Additionally, person in this role is ... manner, and in support of corporate objectives + Act as the quality / validation SME for Change Controls supporting GMP/GLP systems . + Ensure required Standard… more