• Principal Validation Engineer

    J&J Family of Companies (Danvers, MA)
    …robotics, PLC-controlled systems). + Serve as the **subject matter expert (SME)** for process validation , ensuring alignment with FDA 21 CFR Part 820, ISO 13485, ... automated assembly processes** . + Strong working knowledge of ** FDA , ISO, and GHTF validation requirements** ,...working knowledge of ** FDA , ISO, and GHTF validation requirements** , including IQ/OQ/PQ frameworks. + Proven ability… more
    J&J Family of Companies (06/06/25)
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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 (05/10/25)
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  • MES Manufacturing Process Manager

    Takeda Pharmaceuticals (Lexington, MA)
    …solutions (eg Syncade, Rockwell, ProPack Data, Werum PAS-X) + Knowledgeable in FDA validation requirements preferred, including: User Requirement and Design ... Specs, Business Process Procedures, Design Reviews, Requirements gathering + Experience with SDLC (Waterfall/Agile) + Experience developing user requirements, functional specification documents and test scripts for MES projects + Demonstrate understanding of… more
    Takeda Pharmaceuticals (05/15/25)
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  • Project Scheduler

    Stantec (Devens, MA)
    …multi-project environment with cross-functional teams. + Familiarity with GMP regulations, FDA standards, and validation protocols. + Experience supporting ... project schedules for design, engineering, procurement, construction, commissioning and validation activities. + Work closely with project managers, engineers,… more
    Stantec (06/23/25)
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  • Compliance Head, US FDA

    Sanofi Group (Framingham, MA)
    **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, Morristown, NJ **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, ... was possible. Ready to get started? **Main Responsibilities:** . **Ensure US FDA GMP Inspection Readiness, Inspection Activities, Inspection Follow-Up** for US … more
    Sanofi Group (06/03/25)
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  • Senior Validation Engineer

    Takeda Pharmaceuticals (Lexington, MA)
    …a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration ( FDA )/Company guidelines; draft Specification ... and Validation Summary Reports (VSR) etc. per Food Drug Administration ( FDA ) and other US pharmaceutical regulations; Analyze validation data, prepare… more
    Takeda Pharmaceuticals (07/12/25)
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  • Senior Engineer, IT Computer System…

    Bristol Myers Squibb (Devens, MA)
    …careers.bms.com/working-with-us . **Summary:** The Senior Engineer - IT Computer System Validation , Cell Therapy Devens role will provide support to the Digital ... Cell Therapy Facility (CTF) through managing the computerized system validation (CSV) activities / major projects and supporting deviations...systems. + Knowledge of CSV principles, GAMP 5 concepts, FDA 21 CFR Part 11, and data integrity is… more
    Bristol Myers Squibb (07/22/25)
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  • Senior Commissioning/ Validation Specialist

    Stantec (Boston, MA)
    …the designs that support and enhance our communities. The Commissioning and Validation role provides crucial services to confirm equipment and facilities meet the ... hear from you. We have two immediate openings in our Buildings Commissioning/ Validation group for an enthusiastic, diligent and experienced Commissioning / … more
    Stantec (06/17/25)
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  • Engineer III, Validation

    ThermoFisher Scientific (Waltham, MA)
    …Scientific Inc. **LOCATION:** 168 Third Avenue, Waltham, MA 02451 **TITLE:** Engineer III, Validation **HOURS:** Monday to Friday, 8:00 am to 5:00 pm **DUTIES:** * ... and provide supervision as required in the course of this duty; + Conduct validation or qualification tests for new or existing equipment, or software in accordance… more
    ThermoFisher Scientific (06/28/25)
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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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