- FUJIFILM Holdings America Corporation (College Station, TX)
- …applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation ( CSV ) and Lifecycle ... preferred.Working knowledge of engineering principles.Working knowledge and expertise in computerized systems validation . Computer System Validation … more
- FUJIFILM Holdings America Corporation (College Station, TX)
- …platform.Working knowledge of engineering principles.Working knowledge and expertise in computerized systems validation . Computer System Validation ... in the hub of innovation, representing a source of pride for the area.The Computer System Validation ( CSV ) Engineer III, under general direction, will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune 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
- Sunrise Systems Inc (Summit, NJ)
- …thinking for Computerized Systems Familiar with the development of CSV documentation ( Validation Plans, Requirements, Design / Configuration Specifications, ... with the ALCOA+ principles of data integrity, risk-based approaches to validation , Computer Software Assurance (CSA) principles Understanding the concept… more
- Bristol Myers Squibb (Devens, MA)
- …Devens Cell Therapy Facility, including commissioning, qualification, and validation (CQV), computer systems validation ( CSV ), process validation ... QA review and approval and decision making in the areas of process validation , computer system validation , facility, equipment, and utility qualification,… 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
- Digital Prospectors (Portsmouth, NH)
- …of technical expertise, task management, and leadership. + Present and defend the computer systems validation program and acceptance criteria to ... Identify efficiency and process improvements to better streamline the CSV validation strategy and approach. + Document...SDLC regulations including 21CFR part 11, Annex 11, and computer systems validation requirements. +… more
- Lilly (Concord, NC)
- …with the Site Data Leader and Site Tech at Lilly leadership to implement the computer system validation ( CSV ) and Data integrity strategies and culture for ... Lilly subject matter experts (SMEs) of new and existing systems from a Data Integrity and CSV ...validation based upon risk. + Solid knowledge of Computer System Validation process and Data Integrity.… more
- Lilly (Lebanon, IN)
- …of computer systems . **Responsibilities:** + Oversight and support of computer systems validation activities, including the review and approval of ... process to validate, maintain and retire new and existing computer systems . The position will be responsible...all documentation issued to support the validation /qualification of non-GMP and GMP systems , as… more
- Lilly (Indianapolis, IN)
- …Lilly and Company. **Position Summary:** The Associate Director of Quality Engineering and Computer System Validation ( CSV ) is responsible for overseeing the ... Quality Systems related to POINTs Engineering and Computer System Validation processes. The Associate Director...Validation processes. The Associate Director of Engineering and CSV will work across the POINT organization to provide… more
- VTI Life Sciences (Los Angeles, CA)
- … Computer Science, Electrical or Mechanical Engineering preferred + Experience in computer systems validation , Emerson Delta V programming, 21 CFR ... Life Sciences industries. We are looking for an Automation Computer System Validation ( CSV ) Engineer...Delta-V experience for daily support of our client's Automation Systems in the Greater Los Angeles area, CA. This… more
- VTI Life Sciences (San Diego, CA)
- …Practices) GMP and GDP + Developing and executing IQ, OQ, PQ, and TMV + Experience in computer systems validation . 21 CFR Part 11, Vision Systems and ... Life Sciences industries. We are looking for an Automation CSV Engineer for daily support of our client's Automation...collection of systems spans GMP and non-GMP systems , design, build, commission, validation and possible… more
- Mentor Technical Group (Boston, MA)
- …for the development and execution of Computer System Validation ( CSV ) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts as the ... is required. + Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have experience in configuring… more
- Lilly (Lebanon, IN)
- …SDLC (VP, URS, FRS, FS, DS, etc) documentation. + Develop and execute Validation Plan, Validation Strategies, Trace Matrix, Test Protocols/Cases (IQ/IV, OQ/OV, ... and/or Test Scripts as applicable for DCS, PLC, DDC and PAT based systems . + Perform periodic reviews on qualified/validated Automated Systems (Process Control… more
- Mentor Technical Group (College Station, TX)
- …and South America. Responsibilities: + Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure. + ... Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports. + Ensuring documents meet regulatory and… more
- PCI Pharma Services (Bedford, NH)
- …our global network to pioneer and shape the future of PCI. **JOB SUMMARY** The CSV Validation Engineer III/IV will write and assist in writing all validation ... CSV initiatives through document development or other validation activities. The CSV Validation ...Reports, Trace Matrices and Summary Reports associated to validated computer systems + Perform Gap Assessments 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...record and electronic signature assessments. + Author and review computer validation (IQ, OQ, and PQ) supporting… 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
- J&J Family of Companies (Raritan, NJ)
- …responsible for providing quality oversight over a wide range of Equipment and Computer System Validation ( CSV ) activities for qualification/ validation ... Quality Assurance Equipment/ Computer System Validation Specialist II -...validation process on various equipment/instruments, facility and IT systems . + Support successfully transfer process to cGMP facility… more
- Cook Medical (Pittsburgh, PA)
- …Information Technology, and Quality Assurance departments, to establish the philosophy for validation approaches to computer systems and IT infrastructure. ... validation engineers, data governance analysts, etc.) to drive validation activities for computer systems ...along with associated best practices (eg ISPE GAMP) for CSV qualifications. * Demonstratable ability to understand and comply… more
