Process Engineer

MMQCI•Saco, ME

About The Position

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!

Requirements

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

Responsibilities

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