Process/ Validation Engineer

As a Process/Validation Engineer at Avantor, you will optimize Biopharma production processes by implementing process improvements, managing documentation, and ensuring compliance with industry standards. Your expertise in lean manufacturing and six sigma methods will be crucial in analyzing production data and troubleshooting equipment to enhance operational efficiency. This role involves collaboration with cross-functional teams to execute validation protocols and support continuous improvement initiatives in a regulated environment.

The Opportunity:

Avantor, a Global Fortune 500 company is looking for a dedicated Process/ Validation Engineer to optimize our Biopharma Production organization. This Devens, MA role is full-time, on-site.

If you have lean manufacturing/ process experience - let's talk

Minimum Education Requirement:

• Bachelor's degree

Required Experience (4+ yrs):

• Managing the optimization of resources and processes in compliance with company policies/procedures.
• Writing SOPs and training documents to establish standard work and develop initial documents for new processes and systems.
• Troubleshooting equipment and hardware
• Managing data through data collection, modeling, and analysis
• Managing data through cost/benefit analysis, process mapping and/or problem analysis.
• With lean manufacturing practices and the Toyota Production System (TPS; TPMS).
• With six sigma process improvement methods (Green Belt preferred)
• Performs other duties as assigned.

Preferred Experience:

• Conducting risk assessments (IE: PFMEA, FMEA, 5WHYs)
• Assisting in the development and execution of validation protocols for new and in-use equipment and processes.
• Biopharma manufacturing processes
• Cleanroom
• Advanced software application skills (IE. Access / Visio / Minitab)
• Collaboration tools (IE:MS Office Suite)
• Interacting with process owners and users to obtain feedback and to verify performance.
• Regulated environment (FDA or ISO 9001 preferred)
• Direct applicable experience
• Project management
• GMP Manufacturing

How you will thrive and create an impact:

Avantor's Biopharma Production organization works side-by-side with Scientists around the world to enable breakthroughs in medicine, healthcare, and technology at scale. Our expertise and solutions, reliable products, digital solutions and innovation and manufacturing facilities help make life-changing possibilities a reality.

As a Process/ Validation Engineer you 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, designs and conduct feasibility studies, and solve problems. Success will be determined by developing and executing validation of equipment and processes. The successful candidate will create required documentation and aide in team communication. This team member will serve as a resource to site associates in the coordination of work within the scope of assigned projects. Being accountable for analyzing production and supporting other areas as needed while identifying problems, developing countermeasures and implementation is a significant responsibility of this role.

Why Avantor?

Dare to go further in your career. Join our global team of 14,500+ 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

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

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.

Process Engineer, Validation Engineer, Lean Manufacturing, Six Sigma, Biopharma Production, SOP Writing, Troubleshooting, FDA Regulations, Process Improvement, GMP Manufacturing