Process Engineer

Drive Innovation in Biomanufacturing as a Process Engineer at MMQCI

The Manufacturing Process Engineer is responsible for optimizing and maintaining production processes to ensure efficiency, quality, and regulatory compliance. This role troubleshoots operational issues, analyzes performance data, and drives continuous improvement initiatives using methodologies such as LEAN and Six Sigma. The position also supports the transfer of new products into manufacturing, including equipment selection and customization, process scale-up and automation, validation, and training, to ensure safe and reliable operations.

Reporting to the Director of Operations, this role requires a strong biomedical or process engineering background and experience in biomanufacturing and quality systems.

• Evaluate,improveandautomatemanufacturing processes, materials, and equipment to enhance efficiency, quality, and safety
• Support equipment selection, validation, and implementation for new products and scale-up activities
• Establish and monitor process controls; drive continuous improvement initiatives using LEAN methodologies
• Collaborate with internal teams and external partners tooptimizemanufacturing performance and reliability
• Troubleshoot production and equipment issues using structured problem-solving and statistical tools; implement corrective actions
• Support maintenance and technical operations with equipment troubleshooting and vendor coordination
• Participate in CAPA, continuous improvement, and supplier corrective action activities
• Ensure compliance with cGMP, ISO, FDA, and internal safety standards
• Develop andmaintainSOPs, process documentation, and training materials
• Contribute to a strong quality and safety culture, including participation in safety initiatives and investigations

• B.S. degree in Engineering
• 3-5 years of experience ina regulatedbiomanufacturingenvironment(cGMP, ISO, FDA,etc)
• Experiencescalingupmanufacturing and production processes including evaluation,modification,installationandimplementationofautomation
• Process control experience including SPC, control plans,andpFMEAs
• Demonstrated troubleshooting and problem-solving skills(LEAN, Six Sigma,KTor other methodologies)
• Excellent communication skills across all levels of the organization
• High levelof personal productivity, abilityto work independently with minimalsupervisionunder dynamic work conditions
• Well organized, precise,anddetailoriented
• Adaptability and capacity to manage real-time issues in a fast-paced manufacturing or production environment
• Fine motor skills, manual dexterity, and ability to firmly grasp and manipulate objects in the laboratory is required
• Requires visual acuity andaccuratedetection of colors
• Must be able to stand for several hours, lift approximately 50lbsandmanipulate largelabware

• Opportunity to make a meaningful impact within a growing diagnostic company
• Collaborative, mission-driven team environment
• Competitive compensation and benefits

• Medical, dental, and vision insurance
• 401(k) retirement savings plan
• Company profit sharing program
• Paid time off, including vacation, holidays, and sick leave
• Paid Parental Leave Program

The pay range for this position is $75,000 to $130,000 annually

Get to know the MMQCI team!

Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and sells unique quality control products used by hospital laboratories and manufacturers to monitor the accuracy of tests for genetic, oncologic, and infectious diseases. MMQCI has proprietary technologies to stabilize DNA and RNA for use as quality controls and continues to pursue the discovery of novel techniques useful for the development of new quality control products.

MMQCI is conveniently located in beautiful southern coastal Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, sandy beaches, and a plentiful supply of Maine lobsters! Many terrific outdoor activities are easily accessible including hiking, biking, kayaking, fishing,skiingand snowshoeing.

We’reina state-of-the-art facility,locatedin Saco, right next to the Eastern Trail. Come join us!