Jobs
>
Boston

    Validation engineer - Boston, United States - techscienceinfo llc

    techscienceinfo llc
    techscienceinfo llc Boston, United States

    3 weeks ago

    Default job background
    Description

    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 client's policies and procedures.

    Position scope includes local and global enterprise systems as well as SaaS (Software as a Service) solutions. This role will report into the Manager of Validation.

    Perform validation activities supporting requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports.

    Perform system-based risk assessments in determining GxP applicability of the system, associated risk and resulting validation activities per risk.

    Support Validation Team on all aspects of the computer system/computerized equipment lifecycle during projects and operational phase, including but not limited to development, review and execution of validation documentation.

    Provide validation support during the operational phase by performing change impact assessments, determine the required level of testing, authoring and executing test scripts related to the change and change qualification report.

    Support periodic review of computer systems.
    Support periodic user access review of computer systems/computerized equipment.
    Support business administration of the electronic system (ValGenesis) used for validation lifecycle management.
    Support training of end users on the electronic system (ValGenesis) used for validation lifecycle management.
    Support management of Validation Templates in ValGenesis in terms of authoring/updating templates.

    ACADEMIC/TECHNICAL QUALIFICATIONS:
    Bachelor's degree in a Science or Engineering discipline with 5 years relevant experience in computer system validation.

    SPECIALIST/TECHNICAL QUALIFICATIONS/KNOWLEDGE:
    Experience computer systems supporting R&D functions like Clinical, Pharmacovigilance/Drug Safety, Medical Affairs, Supply Chain, Regulatory Affairs and Quality Assurance is a plus
    Experience with ValGenesis is a plus
    Practical experience with quality risk management and risk-based validation approaches.
    Knowledge of cGMP regulations and guidelines including but not limited to U.S.

    Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.

    Understanding of industry standards and best practices for computer system validation such as GAMP 5 and ASTM E2500

    ABILITIES AND JUDGEMENT:
    Ability to objectively review.
    Ability to make judgements in the wider context of quality/compliance
    Ability to perform effective trouble shooting
    Ability to collaborate and work with cross-functional teams
    Ability to manage high volume of simultaneous projects/validation activities
  • BlueSky Innovations

    Validation Engineer CSV

    1 week ago

    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, ...

  • Thermo Fisher Scientific

    Engineer III, Validation

    3 weeks ago

    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 ...

  • VASTEK GROUP INC

    Validation Engineer

    4 weeks ago

    VASTEK GROUP INC Boston, United States Full time

    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 ...

  • 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

    GxP Validation Engineer/Analyst

    3 weeks ago

    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

    Engineer III, Validation

    3 weeks ago

    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

    Engineer III, Validation

    3 weeks ago

    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

    Design Validation Engineer

    4 days ago

    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 ...

  • 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

    QMS Software Validation Engineer

    5 days ago

    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 ...

  • Philips

    QMS Software Validation Engineer

    3 days ago

    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 ...