Process Engineer
Job Summary
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:
WhyYoullLove Working HereBenefits We Offer:
Medical insurance
Dental & Vision insurance
401(k)
Profit Sharing Plan
Vacation
Holidays
Sick leave
Get to know the MMQCI team!
Molecular Quality Controls Inc. (MMQCI) designs develops manufactures and
markets unique quality control products used by hospital laboratories tomonitorthe 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 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 fishingskiingand state-of-the-artfacilitylocatedin Saco right next to the Eastern Trail. Come join us!
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:
- Evaluateimproveandautomatemanufacturing 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
- B.S. degree inEngineering
- 3-5 years of experience ina regulatedbiomanufacturingenvironment(cGMP ISO FDAetc)
- Experiencescalingupmanufacturing and productionprocesses includingevaluationmodificationinstallationandimplementationofautomation
- Process control experience including SPC control plansandpFMEAs
- Demonstratedtroubleshooting andproblem-solvingskills(LEAN SixSigmaKTor 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 preciseanddetailoriented
- 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
WhyYoullLove Working Here
- Opportunity to make a meaningful impact within a growing diagnostic company
- Collaborative mission-driven team environment
- Competitive compensation and benefits
Medical insurance
Dental & Vision insurance
401(k)
Profit Sharing Plan
Vacation
Holidays
Sick leave
Get to know the MMQCI team!
Molecular Quality Controls Inc. (MMQCI) designs develops manufactures and
markets unique quality control products used by hospital laboratories tomonitorthe 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 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 fishingskiingand state-of-the-artfacilitylocatedin Saco right next to the Eastern Trail. Come join us!
Required Experience:
Manager