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!

• 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, K‑T, 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
• Requires visual acuity and accurate detection of colors
• Must be able to stand for several hours, lift approximately 50 lbs and manipulate large labware

• 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