• Remote Technical Writer

    Insight Global (Blue Ash, OH)
    …for the development of new and revised Standard Operating Procedures (SOP), Work Instructions, & Computer System Validation ( CSV ) Test Scripts. The Goal ... of experience technical writing SOPs and Work Instructions Prior experience supporting CSV validation activities Highly proficient in Microsoft Office suite… more
    Insight Global (07/18/25)
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  • Quality Assurance Engineer

    Danaher Corporation (Muskegon, MI)
    …Qualification (PQ), process validation (PV), cleaning validation (CV) and Computer Software Validation ( CSV ) protocols and/or Plans and Reports. + ... and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into...Engineer will be the subject matter expert for the validation strategy and maintain ownership of the Muskegon site… more
    Danaher Corporation (06/27/25)
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  • Engineer - Syncade or PharmaSuite MES…

    Lilly (Concord, NC)
    …or similar is strongly preferred. **Additional Preferences** + Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, GAMP ... the newest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact...needs. Working closely with global and site teams, MES System Engineer will ensure compliance with validation … more
    Lilly (07/22/25)
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  • Engineer - MES System

    Lilly (Indianapolis, IN)
    …for this employment position._ **Additional Preferences** + Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, GAMP ... the latest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact...needs. Working closely with global and site teams, MES System Engineer will ensure compliance with validation … more
    Lilly (06/14/25)
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  • Sr/Lead DeltaV Automation Engineer(remote)

    Cognizant (Atlanta, GA)
    … systems is a plus. . Strong understanding of GMPs, regulatory compliance, and computer system validation ( CSV ) principles. . Excellent communication ... across teams. . Proficient in writing and reviewing protocols, specifications, and validation documents. . Experience with issue tracking systems and managing… more
    Cognizant (07/16/25)
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  • Senior Staff, Software Quality Assurance Engineer

    Stryker (Weston, FL)
    …of AICPA SOC 2 certification requirements or equivalent standards. + Familiarity with GAMP 5, Computer System Validation ( CSV ), and process validation ... with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA, HIPAA,… more
    Stryker (07/16/25)
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  • IT Business Process Analyst III

    Teva Pharmaceuticals (West Chester, PA)
    …changes in accordance with Computer Systems Validation ( CSV ) standards. * Perform day-to-day system administration, maintenance & operational tasks ... to Software Development Life Cycle (SDLC) phases for laboratory computer systems . Ensures that system ...laboratory environment Experience: * Proven experience working as a validation analyst * Extensive experience in regulated biotech or… more
    Teva Pharmaceuticals (07/24/25)
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  • Senior Director, Quality Systems GTS

    BeOne Medicines (Pennington, NJ)
    …Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation ( CSV ). Previous experience in ... experience in building, configuring, and supporting Quality Assurance and/or Quality Control systems , or Master's Degree in Engineering, Computer Science or… more
    BeOne Medicines (07/02/25)
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  • Site Automation, Engineer II

    BeOne Medicines (Pennington, NJ)
    …+ Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation ( CSV ). + Strong experience with ... systems for the shopfloor and process automation systems and Building Automation System , in close...hardware as required by the job. + Experience with computer systems validation practices (GAMP)… more
    BeOne Medicines (06/13/25)
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  • CSV Specialist/Engineer IT Systems

    PACIV (San Juan, PR)
    …solutions servicing the Life Sciences sector, is looking for a Computerized System Validation ( CSV ) Specialist/Engineer IT Systems , for its Puerto Rico ... office. Job Description: The Computerized System Validation ( CSV ) Specialist/Engineer will...Education: Bachelor's degree in Engineering or related science studies ( Computer Systems or Engineering preferred). + Minimum… more
    PACIV (07/13/25)
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