• Engineer, Computer System Validation…

    Bristol Myers Squibb (Devens, MA)
    …more: careers.bms.com/working-with-us . **Summary:** We are seeking a highly skilled and motivated Computer System Validation (CSV) Engineer to join our team at ... + Stay current with industry trends and regulatory updates related to computer system validation . **Qualifications:** + Bachelor's degree in Computer… more
    Bristol Myers Squibb (05/01/25)
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  • Senior Validation Specialist-…

    Regeneron Pharmaceuticals (Cambridge, MA)
    …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
    Regeneron Pharmaceuticals (02/08/25)
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  • Manager, Validation Engineer, Cell Therapy

    Bristol Myers Squibb (Devens, MA)
    …personal lives. Read more: careers.bms.com/working-with-us . **Position: Manager, Validation Engineer, Cell Therapy** **Location: Devens, MA** **Key ... Responsibilities** + Supports equipment qualification and validation activities by providing technical impact assessments and developing sound validation … more
    Bristol Myers Squibb (04/14/25)
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  • Integration Specialist - informatica/AWS

    Sanofi Group (Cambridge, MA)
    …teams to ensure that all integration processes adhere to the required validation protocols for FDA -compliant systems. Provide documentation and support for ... and mitigation strategies) systems are operating efficiently and in compliance with FDA regulations, while also enabling smooth data flows between various systems… more
    Sanofi Group (05/01/25)
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  • Sr Quality Assurance Representative - Digital…

    ThermoFisher Scientific (Cambridge, MA)
    …Services Group (PSG) of Thermo Fisher Scientific, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to data ... safety, and delivering COVID-19 solutions. **Location/Division Specific Information** The Computer System Quality Assurance Team provides quality oversight of… more
    ThermoFisher Scientific (04/26/25)
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  • Quality Engineer 2

    Hologic (Marlborough, MA)
    …industry, or equivalent combination of education and experience + Knowledge of ISO 13485, FDA regulations, and cGMP is required. + Computer literacy is required. ... + Write, review, and/or approve reports for: Test Method Validation , Design Verification, Design Validation , and Process Validation (IQ, OQ, PQ). +… more
    Hologic (05/01/25)
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  • Research Scientist 1 - Immunochemistry

    Charles River Laboratories (Shrewsbury, MA)
    …responsibilities include serving as a Principal Investigator for the development and validation of biomarker, PK and ADA assays (eg: ligand binding assays, enzymatic ... would be responsible for the composition and execution of validation and sample analysis protocols/plan in accordance with company...required to talk, hear and work/ type at a computer . * Specific vision abilities required by this job… more
    Charles River Laboratories (03/04/25)
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  • Engineer, IT Compliance, Devens Cell Therapy…

    Bristol Myers Squibb (Devens, MA)
    …knowledge of regulatory requirements and industry standards related to computer system validation (CSV) requirements (eg, FDA , EMA, GAMP 5, 21 CFR Part 11, ... This role will primarily support the IT Compliance, IT Deviation Management, Computer System Audit, Change Management, Training Management, and the Risk Management… more
    Bristol Myers Squibb (04/18/25)
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  • Quality Control Technician II, Analytical

    Integra LifeSciences (Boston, MA)
    …Quality Control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
    Integra LifeSciences (04/16/25)
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  • Regulatory Affairs Program Manager

    Philips (Cambridge, MA)
    …+ Leads programs/projects focused on regulatory compliance with UDI requirements, Computer System Validation (CSV) and process improvement by applying/utilizing ... of 7+ years' experience in Regulatory Affairs within Global FDA regulated medical device/technology environments, and a minimum of...the product lifecycle, as well as desired experience in Computer System Validation (CSV) and knowledge in… more
    Philips (04/16/25)
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