The Role
The Manufacturing Process Engineer optimizes and automates biomanufacturing processes, troubleshoots equipment and production issues, and drives continuous improvement using LEAN and Six Sigma. Responsibilities include equipment selection, process scale-up, validation, process controls, CAPA, supplier corrective actions, SOP development, training, and regulatory compliance with cGMP, ISO, and FDA standards. The role collaborates with internal teams and vendors to improve manufacturing reliability, quality, safety, and efficiency.
Summary Generated by Built In
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
Why You’ll Love Working Here
Benefits We Offer
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, skiing and snowshoeing. We’re in a state-of-the-art facility, located in Saco, right next to the Eastern Trail. Come join us!
Interested in joining our team? Please submit both a resume and cover letter with your application for consideration.
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
- 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, 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
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, skiing and snowshoeing. We’re in a state-of-the-art facility, located in Saco, right next to the Eastern Trail. Come join us!
Interested in joining our team? Please submit both a resume and cover letter with your application for consideration.
Skills Required
- Bachelor of Science degree in Engineering
- 3-5 years of experience in a regulated biomanufacturing environment
- Experience scaling up manufacturing and production processes, including automation evaluation, modification, installation, and implementation
- Process control experience with SPC, control plans, and pFMEAs
- Troubleshooting and problem-solving experience using LEAN, Six Sigma, KT, or similar methodologies
- Excellent communication skills across all organizational levels
- Ability to work independently with minimal supervision in dynamic conditions
- Strong organization, precision, and attention to detail
- Adaptability and ability to manage real-time issues in manufacturing or production environments
- Fine motor skills and manual dexterity for laboratory work
- Visual acuity and accurate color detection
- Ability to stand for several hours, lift approximately 50 pounds, and manipulate large labware
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
MMQ & Associates, P.C. is a local accounting firm in Scranton, Pennsylvania, providing accounting, tax, assurance, consulting, internal audit outsourcing, business valuation, bookkeeping, payroll, auditing, and tax-planning services. It serves individuals, businesses, government organizations, and public companies across Northeastern Pennsylvania and neighboring regions, including the Pocono and Bethlehem areas, New York, and New Jersey. The firm emphasizes personal service, professional standards, quality control, client value, and long-term relationships.
