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, 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

Required Experience & Skills:

• B.S. degree in Engineering
• 3-5 years of experience in a regulated biomanufacturing environment (cGMP, ISO, FDA, etc)
• 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)
• Excellent communication skills across all levels of the organization
• High level of personal productivity, ability to work independently with minimal supervision under dynamic work conditions
• Well organized, precise, and detail oriented
• 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 and accurate detection of colors
• Must be able to stand for several hours, lift approximately 50 lbs and manipulate large labware

Why You'll Love 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 insurance
• Dental & Vision insurance
• 401(k)
• Profit Sharing Plan
• Vacation
• Holidays
• Sick leave

Get to know the MMQCI team!

https://www.mmqci.com/about/employeespotlight/employee-spotlight.html

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. MMQCI has developed 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, skiing and snowshoeing. We're in a state-of-the-art facility, located in Saco, right next to the Eastern Trail. Come join us!