Process Engineer
MMQCISaco, ME
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Overview
Schedule
Full-time
Education
Engineering (PE)
Career level
Senior-level
Remote
On-site
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Job Description
Drive Innovation in Biomanufacturing as a Process Engineer at MMQCIThe 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: 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!
- 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
Benefits We Offer: - Opportunity to make a meaningful impact within a growing diagnostic company
- Collaborative, mission-driven team environment
- Competitive compensation and benefits
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FAQs About Process Engineer Jobs at MMQCI
What is the work location for this position at MMQCI?
This job at MMQCI is located in Saco, ME, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at MMQCI?
Employer has not shared pay details for this role.
What employment applies to this position at MMQCI?
MMQCI lists this role as a Full-time position.
What experience level is required for this role at MMQCI?
MMQCI is looking for a candidate with "Senior-level" experience level.
What education level is required for this job?
The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.
What benefits are offered by MMQCI for this role?
MMQCI offers following benefits: Health Insurance, Dental Insurance, Vision Insurance, Paid Holidays, Paid Vacation, Paid Sick Leave, and 401k Matching/Retirement Savings for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at MMQCI?
You can apply for this role at MMQCI either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.