Jobs
>
Boston

    Validation Engineer - Boston, United States - VASTEK GROUP INC

    Default job background
    Full time
    Description

    This individual assures validation activities are performed in conformance with applicable Standard Operating Procedures (SOPs) client standards industry best practices and regulatory requirements.

    The individual performs validation program-related activities such as DQ COM IQ OQ PQ CQ RQ etc.
    Essential Duties and Responsibilities

    • Writes and executes commissioning qualification & validation protocols for facilities utilities equipment and computerized systems
    • Writes final reports
    • Resolves protocol discrepancies and deviations
    • Reviews vendor-generated validation protocol packages
    • Supports change control deliverables
    • Responsible for the generation of complex protocols using a risk-based approach that meets current regulatory requirements and industry practicesRequirements
    • Minimum of 0-1 year of experience.
    • BS/MS in Mechanical/Industrial/Manufacturing/Biology/Chemical/Biochemistry/Biomedical Engineering.


  • BlueSky Innovations Tremont City, United States

    We, the Dr. Franz Köhler Chemie GmbH, are a research-intensive and innovative pharmaceutical company in its third generation with two locations in Bensheim and Alsbach. With a highly specialized portfolio of niche products that require extensive expertise and a great deal of resp ...

  • Katalyst Healthcares and Life Sciences

    Validation Engineer

    4 weeks ago


    Katalyst Healthcares and Life Sciences Cambridge, United States

    Responsibilities: Collaborate with stakeholders to gather and define requirements for validation activities · Design and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) · Perform risk as ...

  • Katalyst Healthcares and Life Sciences

    Validation Engineer

    2 days ago


    Katalyst Healthcares and Life Sciences Cambridge, United States

    Responsibilities: Provide validation subject matter expertise / support for equipment and systems in use at Client site which includes Analytical Instruments, Manufacturing Operation Units and CTUs (Controlled Temperature Units). · Ensure the validated status of site facilities, ...

  • techscienceinfo llc

    Validation engineer

    3 weeks ago


    techscienceinfo llc Boston, United States

    Role : Validation engineer · Job Description: · KEY AREAS OF JOB ACCOUNTABILITY: (list of key objectives and quantifying standards): · The holder of this position is charged with supporting computer system/computerized equipment validation activities and ensuring compliance with ...


  • Thermo Fisher Scientific Cambridge, United States OTHER

    Job Description · DUTIES: · Plan and execute validation projects including working with the Thermo Fisher core teams to understand the scope of validation activities and develop schedule, budget, resource plans to meet overall project objectives; · Act as a subject matter expert ...

  • Katalyst HealthCares & Life Sciences

    Validation Engineer

    2 weeks ago


    Katalyst HealthCares & Life Sciences Cambridge, United States

    Responsibilities: Collaborate with stakeholders to gather and define requirements for validation activities · Design and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) · Perform risk a ...


  • WHITE COLLAR TECHNOLOGIES INC Cambridge, United States

    Job Description · Job DescriptionResponsibilities: · Provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for the implementation of analytical assays on new ...

  • GQR

    Validation Engineer

    2 weeks ago


    GQR Waltham, United States

    Title: Validation Engineer (CSV) · Location: Waltham, MA · Status: 6-month contract · Hourly rate: $60 · Please note that this role is not able to provide sponsorship or work on a C2C basis. · Position Overview: · The Computer System Validation Specialist will support the validat ...

  • GQR

    Validation Engineer

    1 week ago


    GQR Waltham, United States

    Title: Validation Engineer (CSV) · Location: Waltham, MA · Status: 6-month contract · Hourly rate: $60 · Please note that this role is not able to provide sponsorship or work on a C2C basis. · Position Overview: · The Computer System Validation Specialist will support the valid ...


  • Thermo Fisher Scientific Cambridge, United States

    DUTIES:Plan and execute validation projects including working with the Thermo Fisher core teams to understand the scope of validation activities and develop schedule, budget, resource plans to meet overall project objectives;Act as a subject matter e Validation, Mechanical Engine ...


  • Thermo Fisher Scientific Cambridge, United States

    Job Description · DUTIES: · Plan and execute validation projects including working with the Thermo Fisher core teams to understand the scope of validation activities and develop schedule, budget, resource plans to meet overall project objectives; · Act as a subject matter expert ...

  • Catalyx North America

    Validation Engineer

    6 days ago


    Catalyx North America Andover, United States

    Catalyx is planning demolition and decommissioning at a client site of the existing Suite E UF Skid and TK3017 Wash Tank, which will include the equipment, process & utility piping, control wiring, and electrical power wiring. As part of this project, the UF skid will be upsized ...

  • Shire Human Genetic Therapies, Inc

    Validation Engineer

    1 week ago


    Shire Human Genetic Therapies, Inc San Francisco, United States Permanent

    Shire Human Genetic Therapies, Inc. is seeking a Validation Engineer - · Process Validation in Lexington, MA to provide validation support for Shire biologics manufacturing operations located in Lexington and Cambridge. Up to 40% remote work allowed. · Full time. $130, - $152, ...

  • GQR

    Validation Engineer

    1 week ago


    GQR Watertown, United States

    Title: Validation Engineer (CSV) · Location: Waltham, MA · Status: 6-month contract · Hourly rate: $60 · Please note that this role is not able to provide sponsorship or work on a C2C basis. · Position Overview: · The Computer System Validation Specialist will support the v ...


  • GCR Professional Services Cambridge, MA, United States

    Sr. Digital Design Verification Engineer · Direct Hire · FTE, Full Benefits... Hybrid, Onsite Cambridge, MA · Security Requirement: · The ability to obtain a US secret clearance is required which requires proof of US citizenship Active secret clearance is preferred · Digital Des ...

  • Kelly Science, Engineering, Technology & Telecom

    Validation Engineer

    1 week ago


    Kelly Science, Engineering, Technology & Telecom Marlborough, United States

    Job Title: Validation Engineer · Pay rate: $71.42 per hour · Duration: 06 months · W2 contract only (No C2C) · Location- Marlborough, MA, 01752 · Description · The Validation Engineer (Mid Level) will be responsible for leading the verification and validation efforts on various ...

  • Katalyst HealthCares & Life Sciences

    Validation Engineer

    2 days ago


    Katalyst HealthCares & Life Sciences Hopkinton, United States

    Roles & Responsibilities: · Perform equipment and system validations. · Develop, review, and approve accurate documentation, as required in cGMP operations. · Provide responsive customer support with emphasis on customer satisfaction. · Work in a collaborative team environment an ...


  • Philips Cambridge, United States

    Looking at the challenges the world is facing today Philips purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, youll be working towards creating a better and fairer future for all. · In this role you have the opportunity to ...

  • Advantage Technical

    validation Engineer

    1 week ago


    Advantage Technical Waltham, United States

    Validation Engineer · Terrific hybrid opportunity to join a growing local pharmaceutical company. We are seeking a Program Manager to join our dynamic team in Waltham, MA. Come and build a satisfying career with our world class staff. We offer a competitive salary, annual bonuse ...


  • Philips Cambridge, United States Full time

    Job Title · QMS Software Validation EngineerJob Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fa ...