3-5 years of experience in regulated biomanufacturing environment (cGMP, ISO, FDA)
Experience in scaling up manufacturing processes including automation
Process control experience including SPC, control plans, and pFMEAs
Demonstrated troubleshooting and problem-solving skills using LEAN or Six Sigma methodologies
Excellent communication skills across all organizational levels
Detail-oriented with strong organizational skills
Ability to manage real-time issues in a fast-paced environment.
Responsibilities
Evaluate, improve, and automate manufacturing processes to enhance efficiency and quality
Support equipment selection and implementation for new products
Establish and monitor process controls, driving continuous improvement initiatives
Collaborate with teams to optimize manufacturing performance
Troubleshoot production and equipment issues, implementing corrective actions
Support maintenance and technical operations with troubleshooting
Contribute to CAPA and supplier corrective action activities
Develop and maintain SOPs and training materials.
Promote a strong quality and safety culture, participating in safety initiatives.
Benefits
Medical insurance
Dental & Vision insurance
401(k)
Profit Sharing Plan
Vacation
Holidays
Sick leave
Full Job Description
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 inEngineering
3-5 years of experience ina regulatedbiomanufacturingenvironment(cGMP, ISO, FDA,etc)
Experiencescalingupmanufacturing and production processes includingevaluation,modification, installation and implementation ofautomation
Process control experience including SPC, control plans, and pFMEAs
Demonstratedtroubleshooting andproblem-solvingskills(LEAN, SixSigma, KTor 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,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 is required
Requires visual acuity and accurate detection of colors
Must be able to stand for several hours, lift approximately 50lbs and manipulate large labware
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
