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Process and Validation Engineer

Process and Validation Engineer

AvantorDevens, MA, United States
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The Opportunity :

Avantor is looking for a Process and Validation Engineer to be responsible for multiple phases of manufacturing processes and process improvement projects. The Process Engineer implements process improvements to meet quality standards, designs and conducts feasibility studies, and solves problems.

This role will be a full-time position based out of our Devens, MA office.

You will have the opportunity to develop and execute validation of equipment and processes, create necessary documentation and aides in communication to personnel and serve as a resource to site associates.

What we're looking for :

  • Education : Bachelor's degree in Industrial Engineering, Chemical Engineering, Mechanical Engineering or relatedarea.
  • Experience :

4+ years related process engineering experience desired.

Experience in regulated environments (FDA or ISO 9001 preferred).

2+ years experience with GMP, cleanroom and / or biopharma manufacturing processes and environments desired.

  • Additional Qualifications :
  • Project management experience a plus.

    MS Office Suite experience.

    Advanced software application skills (IE. Access / Visio / Minitab) desired.

    Knowledge of Lean Manufacturing practices and the Toyota Production System (TPS).(TPMS).

    Knowledge of Six Sigma process improvement methods (Green Belt preferred.

    How you will thrive and create an impact :

  • Responsible for analyzing production and supporting other areas as needed, identifying problems, developing countermeasures and implementation.
  • Manages data through data collection, data modeling, data analysis, cost / benefit analysis, process mapping and / or problem analysis.
  • Conduct risk assessments such as PFMEA, FMEA, 5WHYs, etc.
  • Assist with the development and execution of validation protocols for new and in use equipment and processes.
  • Systematically interacts with process owners and users to obtain feedback and to verify performance.
  • Manages the optimization of resources and processes in compliance with company policies / procedures.
  • Writes SOPs and training documents to establish standard work and develops initial documents for new processes and systems.
  • Troubleshoot equipment and hardware issues, as required.
  • Performs other duties as assigned.
  • Environmental Working Conditions and Physical Effort :

    The work environment characteristics and physical effort described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Typically works in a production / clean room environment with adequate lighting and ventilation and a normal range of temperature and noise level. The Process / Validation Engineer may occasionally travel to other Avantor locations or customer sites.

    Disclaimer :

    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

    Why Avantor?

    Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

    The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

    We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

    EEO Statement :

    We are an Equal Employment / Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state / province, or local law.

    If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.comand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

    For more information about equal employment opportunity protections, please view the Know Your Rights poster.

    3rd Party Non-Solicitation Policy :

    By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

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    Validation Engineer • Devens, MA, United States

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