Process and Validation Engineer

Company: Avantor
Location: Leominster
Posted on: February 20, 2025

Job Description:

The Opportunity: Avantor is seeking a Process and Validation Engineer to optimize our Biopharma Production organization.The Process and Validation Engineer will be responsible for multiple phases of manufacturing processes and process improvement projects. This high demand role will Implement process improvements to meet quality standards, design and conduct feasibility studies, and solve problems.This is a full-time position based out of our Devens, MA location.What we're looking for:

• Education:
• Bachelor's degree.
• Experience:
• 4+ years related experience.
• GMP and biopharma manufacturing process experience desired.
• Additional Qualifications:
• Experience conducting risk assessments (IE: PFMEA, FMEA, 5WHYs).
• Ability to assist in the development and execution of validation protocols for new and in-use equipment and processes.
• Familiarity with lean manufacturing practices and the Toyota Production System (TPS; TPMS) a plus.
• Experience with six sigma process improvement methods (Green Belt preferred) desired.
• Advanced software application skills (IE. Access / Visio / Minitab).
• Ability to interface with process owners and users to obtain feedback and to verify performance.
• Experience working in a regulated environment (FDA or ISO 9001 preferred).
• Project management experience a plus.How you will thrive and create an impact:
  • Develop and execute validation of equipment and processes.
  • Create required documentation and aide in team communication.
  • Serve as a resource to site associates in the coordination of work within the scope of assigned projects.
  • Be accountable for analyzing production and supporting other areas as needed while identifying problems, developing countermeasures and implementation.
  • Manage the optimization of resources and processes in compliance with company policies/procedures.
  • Write SOPs and training documents to establish standard work and develop initial documents for new processes and systems.
  • Troubleshoot equipment and hardware.
  • Manage data through data collection, modeling, and analysis.
  • Manage data through cost/benefit analysis, process mapping and/or problem analysis.
  • Perform 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 and 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 Equal Employment Opportunity is THE LAW Poster , EEO is the Law Poster Supplement , and Pay Transparency Non-Discrimination Provision . 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.

Keywords: Avantor, Leominster , Process and Validation Engineer, Engineering , Leominster, Massachusetts