• Senior Validation Specialist-…

    Regeneron Pharmaceuticals (Cambridge, MA)
    …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part… more
    Regeneron Pharmaceuticals (05/10/25)
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  • Manager, Validation Engineer, Cell Therapy

    Bristol Myers Squibb (Devens, MA)
    …Regulatory requirements. + Familiarity with SDLC, CSV deliverables, distributed control systems and automation (GAMP) validation concepts allows this individual ... their personal lives. Read more: careers.bms.com/working-with-us . **Position: Manager, Validation Engineer, Cell Therapy** **Location: Devens, MA** **Key Responsibilities**… more
    Bristol Myers Squibb (06/26/25)
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  • Manager, Automation Engineering- Onsite

    AbbVie (Worcester, MA)
    …Operations, Quality, IT and Maintenance. + Manage and supports control system including standalone Manufacturing equipment, systems upgrades, data migrations ... Data Historian systems . + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP,...PI, Rockwell PLC are required. + Direct experience with system development and validation , including development of… more
    AbbVie (06/17/25)
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  • Integration Specialist - informatica/AWS

    Sanofi Group (Cambridge, MA)
    …processes adhere to the required validation protocols for FDA -compliant systems . Provide documentation and support for system validation , including ... 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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  • Regulatory Affairs Program Manager

    Philips (Cambridge, MA)
    …results. + Leads programs/projects focused on regulatory compliance with UDI requirements, Computer System Validation (CSV) and process improvement by ... better management throughout the product lifecycle, as well as desired experience in Computer System Validation (CSV) and knowledge in 510K, PMA,… more
    Philips (04/16/25)
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  • Automation Engineer II

    Catalent Pharma Solutions (Chelsea, MA)
    …to GMP standards. Performs 21CFR Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements + Prepares standard operating ... new and existing control equipment + Trains users on control system functionality (Programmable Logic Controller, Computer /Control Networks, Control Computers… more
    Catalent Pharma Solutions (06/13/25)
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  • Senior Design Assurance Engineer

    Hologic (Marlborough, MA)
    …experienced **Senior Design Assurance Engineer** with a strong background in software and systems engineering to join our dynamic team. In this role, you will ... expertise in design control, risk management, software development, and quality systems to ensure our medical devices, particularly those involving **Software as… more
    Hologic (06/17/25)
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  • Quality Technician

    Teleflex (Mansfield, MA)
    …experience of working in the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems , strongly desired * Experience in ... and corrective actions in support of the Teleflex Medical Quality System and manufacturing processes. Adhere safety, manufacturing and Quality procedures and… more
    Teleflex (06/20/25)
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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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  • Sr. Software Quality Engineer

    Fresenius Medical Center (Lawrence, MA)
    …Understanding of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and ... and/or guide software project teams to ensure that software systems are compliant with procedures and Regulations such as...as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning… more
    Fresenius Medical Center (06/14/25)
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