Process Engineer 1

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

The Process Engineer is responsible for developing the manufacturing process train for custom products in GMP manufacturing and bringing in new manufacturing equipment. This role works cross-functionally with Manufacturing, Process and Analytical Development, Engineering, Validation, and customers to determine process needs and requirements for transferring production processes into the GMP space.

• Assesses facility fit, equipment needs, and manufacturing capabilities for potential new products.
• Determines process needs/requirements for processes moving from Development to GMP.
• Creates detailed process overviews and flow diagrams.
• Identifies and orders equipment for use in GMP manufacturing.
• Establishes manufacturing equipment specifications.
• Generates, reviews, and approves engineering, manufacturing, and quality procedures necessary to support equipment qualification and operation of equipment in GMP manufacturing (procedures and product-specific recipes).
• Initiates, reviews/approves equipment change request.
• Develops and/or implements systems improvement projects and support.
• Maintenance and Manufacturing groups in resolving technical and engineering issues.
• Supports Manufacturing and Maintenance groups in troubleshooting manufacturing equipment.
• Supports Validation in Equipment and Process Validation activities per GMP regulation.
• Facilitates training for individuals involved in the operation and maintenance of processes and equipment introduced to the manufacturing department.

Who You Are

Minimum Qualifications:

• Bachelors Degree in Engineering (eg. Electrical, Mechanical, or Chemical) or other Life Science discipline.
• 2 + years' experience in GMP Operations.

Preferred qualifications:

• Comprehensive technical knowledge and understanding of GMP manufacturing equipment and biologics production processes.
• Experience with AKTA and Mobius systems is highly preferred.
• Excellent attention to detail and ability to effectively manage multiple projects.
• Effective communication and engagement skills (verbal, written, listening) - ability to work with internal departments and customers.
• Able to build a culture of trust and business driven innovation. Work with internal organizations to solve on-going issues within the team.
• Communicate and lend guidance on day-to-day workflow and overcoming challenges related to completing projects.

RSREMD

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html