• Manager, Cleaning Validation…

    Bristol Myers Squibb (Devens, MA)
    …to work and manage within a regulatory environment. + Knowledge of regulatory validation requirements including FDA , EMA and all other Worldwide Regulatory ... personal lives. Read more: careers.bms.com/working-with-us . **Position:** Manager, Cleaning Validation , Validation Engineering **Location** : Devens, MA… more
    Bristol Myers Squibb (05/08/25)
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  • Senior Validation Specialist- Computer…

    Regeneron Pharmaceuticals (Cambridge, MA)
    …and immunology. You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory ... We are seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized...11, GAMP 5, and Annex 11. **As a Senior Validation Specialist, a typical day might include:** + Planning… more
    Regeneron Pharmaceuticals (02/08/25)
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  • Principal Scientist, Lab Head Quality Processes

    Sanofi Group (Cambridge, MA)
    …with industry's best practices in bioanalytical assay development and regulatory expectations ( FDA and EMA) for validation of PK, immunogenicity and biomarker ... + Serve as system administrator for laboratory software and facilitate the validation and implementation of quality systems in the laboratory. + Program, maintain… more
    Sanofi Group (04/20/25)
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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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  • Senior Commissioning/ Validation Specialist

    Stantec (Boston, MA)
    Senior Commissioning/ Validation Specialist - ( 250000TF ) **Description** Stantec Buildings is on a mission to become the world's leading integrated design practice. ... the designs that support and enhance our communities. The Commissioning and Validation role provides crucial services to confirm equipment and facilities meet the… more
    Stantec (03/29/25)
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  • Validation Lead, Quality Assurance

    Astellas Pharma (Westborough, MA)
    ** Validation Lead, Quality Assurance** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven ... programs. AIRM is headquartered in Massachusetts. Astellas is announcing a ** Validation Lead, Quality Assurance** opportunity at their **Astellas Institute for… more
    Astellas Pharma (03/25/25)
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  • Senior Validation Engineer

    AbbVie (Worcester, MA)
    …Center in Worcester, MA is seeking an Engineer with significant experience in the validation of biologics equipment to join the Validation Engineering Group. The ... renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA /GMP regulated environment. The engineer will work in a multi-disciplinary team… more
    AbbVie (03/20/25)
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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 ... strategies) systems are operating efficiently and in compliance with FDA regulations, while also enabling smooth data flows between...while adhering to regulatory compliance (21 CFR Part 11, FDA REMS guidelines). + Work closely with QA and… more
    Sanofi Group (05/01/25)
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  • Senior Laboratory Technologist - Assay Development

    Bio-Techne (Waltham, MA)
    …novel assays intended for diagnostic use at Exosome Diagnostics (ExoDx), + Verification/ Validation of assays that are FDA -approved, EUA-approved, FDA ... both internal and external collaborations. Technology transfer, operationalization, verification, and validation , of nucleic and protein assays are all in scope.… more
    Bio-Techne (04/15/25)
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  • Supplier Quality Engineering Intern

    ZOLL Medical Corporation (Chelmsford, MA)
    …departments with the day-to-day issues relating to supplier certification, validation and quality. Maintain quality systems associated with supplier management. ... with reviews of supplier performance data, in evaluation and validation of supplier change requests, generates brokerage component MCOs...with standards and regulations such as ISO13485, IS09001, and FDA 21 CFR Part 820. * Must be currently… more
    ZOLL Medical Corporation (04/02/25)
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