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.

If you are a detail-oriented engineer with a passion for continuous improvement and high-quality manufacturing, we would love to hear from you!

What You Will Get to Do

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

Required Experience & Skills

B.S. degree in Engineering

3-5 years of experience ina regulatedbiomanufacturingenvironment(cGMP, ISO, FDA,etc)

Experiencescalingupmanufacturing and productionprocesses includingevaluation,modification,installationandimplementationofautomation

Process control experience including SPC, control plans,andpFMEAs

Demonstratedtroubleshooting andproblem-solvingskills(LEAN, SixSigma,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-timeissues in a fast-paced manufacturing or production environment

Fine motor skills, manual dexterity, and ability to firmly grasp and manipulate objects in the laboratory isrequired

Requires visual acuity andaccuratedetection of colors

Must be able to stand for several hours, lift approximately 50lbsandmanipulate largelabware

WhyYou’llLove Working Here

Opportunity to make a meaningful impact within a growing diagnostic company

Collaborative, mission-driven team environment

Competitive compensation and benefits

Benefits We Offer

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

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-artfacility,locatedin Saco, right next to the Eastern Trail. Come join us!

#J-18808-Ljbffr