• Computer Systems Validation

    Unither Pharmaceuticals (Rochester, NY)
    Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products ... completed by an external company, the computer systems validation (CSV) specialist will...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and… more
    Unither Pharmaceuticals (02/06/25)
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  • Senior Validation Specialist

    Regeneron Pharmaceuticals (Cambridge, MA)
    We are seeking a highly skilled, self-motivated **Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory ... 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might include:**... validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing,… more
    Regeneron Pharmaceuticals (02/08/25)
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  • QC Validation Area Specialist

    Novo Nordisk (Petersburg, VA)
    …and help us make what matters. The Position Plan, manage & performing laboratory validation activities on computer software systems . This role will also ... protocols preferred + Experience in managing projects preferred + Experience with electronic validation systems (TIMS) and SAP PM and QM module a plus + Working… more
    Novo Nordisk (03/22/25)
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  • CSV Automation Specialist

    VTI Life Sciences (San Diego, CA)
    …companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that ... Test Scripts. + 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation . + Must have experience working in an… more
    VTI Life Sciences (04/18/25)
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  • Senior Quality Validation Specialist

    Curia (Rensselaer, NY)
    …protocols and master plans, supervises validation activities such process/ equipment/ cleaning/ computer system validation etc. + Review and approve lab ... Senior Quality Assurance Validation Specialist in Rensselaer, NY Build...special projects as directed by management + Perform the computer system periodic reviews in coordination with… more
    Curia (04/10/25)
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  • Principal QA Validation Specialist

    Regeneron Pharmaceuticals (Troy, NY)
    Specialist would also plan, coordinate and participate in compliant computer system validation (CSV) process for systems which require formal ... QA Validation Specialist to support validation and qualification of computer systems...following: + Generates, executes and/or reviews master and completed computer system (s) qualification and validation more
    Regeneron Pharmaceuticals (03/25/25)
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  • Sr. Specialist /Principal Specialist

    Boehringer Ingelheim (St. Joseph, MO)
    …staff and other departments. + Leads and actively supports strategic direction of validation philosophies, improve overall validation system and process flow ... office application software (MS-Word, MS-Excel, MS-Outlook, PowerPoint). **Requirements for a Sr. Specialist Validation ** + A BS degree from an accredited… more
    Boehringer Ingelheim (02/07/25)
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  • Lead Specialist , QA Validation

    Catalent Pharma Solutions (Harmans, MD)
    …This position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the ... **Lead Specialist , QA Validation & Engineering** Catalent...completion in a Quality role. + Support the Computerized System Validation Lifecycle to ensure compliance to… more
    Catalent Pharma Solutions (04/26/25)
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  • Senior Specialist , Validation

    Bristol Myers Squibb (Warren, NJ)
    …and manufacturing computerized systems + Strong experience writing and executing system validation & equipment qualification documents + Ability to interact ... and change controls. **Key Responsibilities:** + Implements and maintains all validated computer systems in compliance with policies, guidelines and procedures.… more
    Bristol Myers Squibb (05/03/25)
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  • Sr. QA Manager, Computer System

    Boehringer Ingelheim (Ridgefield, CT)
    …Approach depending on process and technical risks Proactive and consultative engagement of the Computer System Validation role within agile projects 2. Guide ... framework by conducting self-developed, process adapted training. Give active feedback into the Computer System Validation (CSV, Management System Owner… more
    Boehringer Ingelheim (04/30/25)
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