Process Engineer
Not Disclosed•Full-TimeOn-site
location_on21, Blunt Lane, Saco, York County, Maine, 04072, United States
About the Team
Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and markets unique quality control products used by hospital laboratories to monitor the accuracy of tests for inherited disease, pharmacogenetics, oncology, and infectious diseases. Our team is dedicated to stabilizing DNA and RNA for use as quality controls and continues to pursue the discovery of novel techniques for new product development.
We are a collaborative, mission-driven team located in a state-of-the-art facility in Saco, Maine. Situated right next to the Eastern Trail, our office is minutes from the Maine Turnpike and Portland International Jetport, offering easy access to Boston. Our location provides a vibrant lifestyle with fabulous restaurants, sandy beaches, and plentiful outdoor activities like hiking, biking, kayaking, fishing, and skiing.
About the Role
As a Manufacturing Process Engineer, you will drive innovation in biomanufacturing by optimizing and maintaining production processes to ensure efficiency, quality, and regulatory compliance. This role exists to support the transfer of new products into manufacturing, handling everything from equipment selection and customization to process scale-up, automation, and validation.
You will be the bridge between technical innovation and reliable operations. Your day will involve troubleshooting operational issues, analyzing performance data, and leading continuous improvement initiatives using LEAN and Six Sigma methodologies. You will collaborate with internal teams and external partners to optimize manufacturing performance while ensuring strict adherence to cGMP, ISO, and FDA standards. Reporting to the Director of Operations, you will contribute to a strong quality and safety culture, developing documentation and training materials to empower the team.
Join Our Community
We invite detail-oriented engineers with a passion for continuous improvement to join our growing diagnostic company. If you are looking for a role where you can make a meaningful impact within a supportive environment, we would love to hear from you.
To learn more about our culture and meet the team, please visit our Employee Spotlight.
Equal Opportunity Employer
MMQCI is an equal opportunity employer committed to building a diverse and inclusive workforce. We consider qualified applicants regardless of background, race, religion, gender, or other protected characteristics.
Work location
Work model: On-site
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Skills, education and keywords
Skills: Biomanufacturing, CGMP, Iso, Fda, Lean, Six Sigma, KT, SPC, Control Plans, Pfmeas.
Education: B.S. degree in Engineering required.
Frequently asked questions about Process Engineer at MMQCI-Maine Molecular Quality Controls Inc.
What does a Process Engineer at MMQCI-Maine Molecular Quality Controls Inc. do?expand_more
Day-to-day, the Process Engineer at MMQCI-Maine Molecular Quality Controls Inc. will support equipment selection, validation, and implementation for new products and scale-up activities; collaborate with internal teams and external partners to optimize manufacturing performance and reliability; troubleshoot production and equipment issues using structured problem-solving and statistical tools; and ensure compliance with cgmp, iso, fda, and internal safety standards.
What are the requirements for this Process Engineer role?expand_more
MMQCI-Maine Molecular Quality Controls Inc. is looking for candidates who meet the following requirements: B.S. degree in Engineering; 3-5 years of experience in a regulated biomanufacturing environment (cGMP, ISO, FDA); Experience scaling up manufacturing and production processes including evaluation, modification, installation and implementation of automation; Process control experience including SPC, control plans, and pFMEAs; Demonstrated troubleshooting and problem-solving skills (LEAN, Six Sigma, KT or other methodologies); and Must be able to stand for several hours, lift approximately 50 lbs and manipulate large labware.