Process Engineer

MMQCI; 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 is seeking a Process Engineer to optimize and maintain production processes, ensuring efficiency, quality, and regulatory compliance. The role involves troubleshooting, data analysis, and driving continuous improvement across cGMP environments.

You will support technology transfer, scale-up, automation, validation, and training, reporting to the Director of Operations. This position requires a strong biomedical or process engineering background and hands-on biomanufacturing experience.

Qualifications

• B.S. degree in Engineering.
• 3–5 years of experience in regulated biomanufacturing (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, or KTOR).

Responsibilities

• Evaluate, improve and automate manufacturing 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 to optimize manufacturing 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 and maintain SOPs, process documentation, and training materials.
• Contribute to a strong quality and safety culture, including participation in safety initiatives and investigations.

Skills

LEAN

Six Sigma

Problem solving

Communication

Independence

Education

B.S. in Engineering

Tools

SPC

pFMEA

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.

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!