Process Engineer

MMQCI-Maine Molecular Quality Controls Inc.; Saco (ME); On-site; USD 75,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement savings plan

Company profit sharing program

Paid time off, including vacation,hols

Paid Parental Leave Program

Job summary

MMQCI-Maine Molecular Quality Controls Inc. in Saco, ME, is seeking a driven Process Engineer to optimize and maintain biomanufacturing processes, improve yields, and ensure regulatory compliance.

You will lead process scale-up, automation, validation, and training, using LEAN and Six Sigma to drive CAPA and continuous improvement, reporting to the Director of Operations.

Qualifications

• B.S. degree in Engineering required.
• 3–5 years of experience in regulated biomanufacturing (cGMP, ISO, FDA).
• Experience scaling up manufacturing and automation implementation.
• Process control experience including SPC, control plans, and PFMEAs.
• LEAN/Six Sigma problem-solving skills or equivalent.
• Excellent communication across all levels of the organization.
• High personal productivity with minimal supervision.
• Well organized, precise, and detail oriented.
• Adaptability to fast-paced manufacturing environments.
• Fine motor skills and color-detection abilities in the lab.

Responsibilities

• Evaluate, improve and automate manufacturing processes, materials and equipment.
• Support equipment selection, validation, and implementation for new products.
• Establish and monitor process controls; drive continuous improvement.
• Collaborate with internal teams and external partners to optimize performance.
• Troubleshoot production and equipment issues using structured problem-solving.
• Support maintenance with equipment troubleshooting and vendor coordination.
• Participate in CAPA, continuous improvement and supplier corrective actions.
• Ensure compliance with cGMP, ISO, FDA and internal safety standards.
• Develop and maintain SOPs, process documentation and training materials.
• Contribute to a strong quality and safety culture.

Skills

LEAN

Six Sigma

SPC

Troubleshooting

cGMP

Communication

Independent work

Detail oriented

Manual dexterity

Color vision

Education

B.S. in Engineering

Job description

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.

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 inEngineering
• 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

Get to know the MMQCI team! https://www.mmqci.com/about/employee-spotlight/employee-spotlight.html

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!