- 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
- Amgen (Holly Springs, NC)
- …reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation . + Provide quality ... DTI platforms to ANC, be the QA expert on Computer System Validation ( CSV ) and...Engineering and/or Information technology experience and/or Quality oversight of computer systems validation experience Or… more
- ThermoFisher Scientific (Carlsbad, CA)
- …global team members. . Familiarity with Good Manufacturing Practices (GMP or GxP) and Computer Systems Validation ( CSV ). . Strong product/project/product ... leaders to define and deliver commitments: demonstrating implementation of technologies, systems , process improvements, PPI, and agile methods with leadership for… more
- ICU Medical (Austin, TX)
- …work extended days, weekends and holidays as required to meet deadlines. *Experience with CSV ( Computer Systems Validation ), Data Integrity, 21 CFR ... of validation plans for facilities, utilities, critical equipment, control systems , and software etc. This includes validation , periodic reviews and… more
- Curia (Albuquerque, NM)
- …+ Minimum 5 years' experience working in the cGMP regulated industry specific to computer systems validation Preferred qualifications: + Validation ... Senior CSV Systems Engineer Albuquerque, NM Curia... Engineer 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 (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
- Insight Global (Rahway, NJ)
- …in Rahway, NJ. This individual will lead Quality Assurance oversight for computer system validation matters within the Global Development Quality Organization. ... promote and build Quality Management System elements into the end-to-end computer system validation process, thereby promoting permanent inspection readiness.… 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
- Amicus Therapeutics (Princeton, NJ)
- …Systems team with responsibility for the Quality Management Systems (QMS), Computer System Validation ( CSV ), and Continuous Improvement efforts. This ... Computer System Quality Assurance: + Oversee the quality of all computer systems used in GxP environments, ensuring compliance with relevant standards and… 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
- Bristol Myers Squibb (Summit, NJ)
- …products. The position requires knowledge of Manufacturing Systems , SDLC methodologies, Computer System Validation ( CSV ), Computer System Assurance ... partners to implement site lifecycle strategies aligned with BMS CSV and GAMP guidance. + Align and contribute to...+ Knowledge of Manufacturing Systems Technologies and Computer Systems Validation with an… 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
- Bristol Myers Squibb (Summit, NJ)
- …for Computerized Systems . + Familiar with the development of CSV documentation ( Validation Plans, Requirements, Design / Configuration Specifications, Test ... global EMES team to create, manage, and improve computerized systems /Recipes validation deliverables for electronic systems... CSV . + Work with QA to ensure CSV validation deliverables are prepared without compliance… more
- Robert Half Technology (Sunnyvale, CA)
- …Repetitive Manufacturing. + Ensure compliance with industry standards and regulations, including CSV ( Computer Systems Validation ), particularly within ... module with SAP S/4 HANA. + Bachelor's degree in Computer Science, Information Systems , or related field. + Excellent communication and interpersonal skills.… 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