Senior Validation Engineer

Company Description

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AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .

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Job Description

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Purpose

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AbbVie Bioresearch Center in Worcester, MA is seeking an Engineer with significant experience in the validation of biologics equipment to join the Validation Engineering Group.

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The selected candidate will be responsible for commissioning and qualification activities associated with capital projects involving the installation and/or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA/GMP regulated environment. The engineer will work in a multi-disciplinary team environment.

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Responsibilities:

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  Prepare validation test protocols, set validation strategy, perform/coordinate validation testing for capital projects of different complexity in concert with all stakeholders, and analyze/assemble test results to create summary reports as required

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  Execute assigned projects, jobs and tasks according to schedule prepared by Engineering Project Management

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  Provide input on risk assessments and system classifications

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  Review new equipment specifications

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  Manage continuous improvement projects and drive to completion

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  Mentor and guide junior engineers and validation associates in the development and execution of equipment change control plans and qualification/validation test protocols

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  Work with appropriate departments and personnel to resolve validation testing issues

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  Advise other departments on SOPs related to validation projects

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  Maintain 100% on time training

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  Achieve Site, Department and Group performance metrics

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  Complete other special projects and assignments as required

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  Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs

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Qualifications

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Key Stakeholders

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Engineering Management

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Operations Management

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EH&S Management

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R&D Management

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Additional Information

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  BS Degree in engineering or technical discipline with a minimum of minimum of 5+ years of experience supporting biologics manufacturing through validation of biologics equipment or processes.

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  An understanding of basic unit operations involving cell culture and protein purification is required

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  Working knowledge of bioreactors, sanitary equipment, hygienic piping, process instrumentation and controls is required

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  Familiarity with Clean-In-Place and Steam-In-Place theory and techniques is required

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  Experience with risk-based approach to commissioning and qualification preferred

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  Experience with temperature mapping of environmental chambers, autoclave validation is desired

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  Familiarity with distributed control systems and process logic controllers is required

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  Must have familiarity with P&IDs, loop diagrams, etc.

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  Must have hands-on experience on the Kaye Validator

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  Familiarity with project management is preferred

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  Experience with continuous improvement to streamline practices & procedures is preferred

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  Adherence to cGMP and GDP is required

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  Strong technical writing skill is required

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  Strong organizational, prioritization, technical, mechanical, and communication skills as well as experience in a GMP environment are preferred

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  Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously

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  Must demonstrate strong interpersonal & teamwork skills

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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.? Equal Opportunity Employer/Veterans/Disabled.

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US & Puerto Rico only - to learn more, visit

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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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