Process Engineer

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 an engineering position responsible for supporting the manufacture and testing of high purity filters, prioritizing safety, and maintaining a focus on quality, process control, electro-mechanical assembly, and material handling. Also, this position is responsible for establishing operating specifications and implementing and improving manufacturing techniques. Closely monitors performance of machinery, automated equipment, and tools to verify their efficiency and investigates and initiates corrective action for challenging problems and deficiencies to ensure product quality. This position works with other engineers to ensure process stability with a focus on maximizing safety, quality, yields, and productivity and requires collaboration with cross functional team to assess risk, disposition product, and resolve problems. Daily tasks to include the following:

• Maintains efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques.
• Exchanges ideas with other team members and participates in process improvements and changes.
• Works cooperatively and effectively with cross functional peers.
• Takes responsibility for project tasks and drives to meet deadlines.
• Completes process engineering assessments and uses data to appropriately disposition product.
• Leads process support on Root Cause Analysis (RCA), Corrective Action Preventive Action (CAPA), implementing robust solutions to address root cause of issues.
• Generates, reviews, and approves engineering, manufacturing, and quality procedures necessary to support production operation, equipment validation/revalidation, and product launch.
• Ensures adherence to Current Good Manufacturing Practices (cGMP).
• Leads and implements changes to minimize process waste and variation, leads yield improvement and product performance initiatives.
• Reviews capital equipment fabrication activities to ensure manufacturing, installation, and operational testing conform to industry standards, and user requirements.
• Generates capital requests to support new processes and capital equipment purchase.
• Participates in and leads equipment and process validations activities, including protocol and report writing, review and execution
• Initiate, reviews/approves change requests in Change Management system.

Physical requirements:

• Physical flexibility to interact with and troubleshoot machinery and equipment.
• Exposure to chemical reagents.
• Physical flexibility to interact with and troubleshoot machinery and equipment.
• Sit, stand, and walk for extended periods of time.
• Frequent lifting/carrying of 11-25 lbs., Occasional lifting/carrying of 26 - 50 lbs.
• Bend, squat, stoop, and kneel.
• Pinch, grasp, and manipulate objects consistently and regularly.

Who You Are

Minimum Qualifications:

• Bachelor's degree in Mechanical engineering, Chemical Engineering or other engineering discipline.

OR

• High school diploma or GED.
• 8+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting automated or manual assembly processes.

Preferred Qualifications:

• Master's degree in in Mechanical engineering, Chemical Engineering or other engineering discipline.

• Electro-Mechanical, instrument and pneumatic knowledge along with 2+ years of experience applying this knowledge to process/equipment troubleshooting.
• Experience analyzing data sets, applying statistical analysis principles, and clearly summarizing conclusions/results.
• Familiarity with EH&S, ISO, cGMP, and other regulatory requirements in a manufacturing environment.
• Experience reading and understanding basic mechanical and electrical drawings and P&ID's.
• Experience with Microsoft products, Minitab, and CAD software packages.
• Read and understand basic mechanical and electrical drawings and P&IDs.
• Understand safe work practices and experience in lockout, tag out, electrical safety, etc.
• Lean/Six Sigma experience, with green or black belt.
• Strong communication skills.

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