Biomanufacturing Process Engineer – Lean & Automation

MMQCI; Saco (ME); On-site; USD 75,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement savings plan

Company profit sharing program

Paid time off, including vacation,hols

Paid Parental Leave Program

Job summary

MMQCI is seeking a Process Engineer to optimize and maintain production processes, ensuring efficiency, quality, and regulatory compliance. The role involves troubleshooting, data analysis, and driving continuous improvement across cGMP environments.

You will support technology transfer, scale-up, automation, validation, and training, reporting to the Director of Operations. This position requires a strong biomedical or process engineering background and hands-on biomanufacturing experience.

Qualifications

• B.S. degree in Engineering.
• 3–5 years of experience in regulated biomanufacturing (cGMP, ISO, FDA).
• 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, or KTOR).

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.

Skills

LEAN

Six Sigma

Problem solving

Communication

Independence

Education

B.S. in Engineering

Tools

SPC

pFMEA

Job description

MMQCI is seeking a Process Engineer to optimize and maintain production processes, ensuring efficiency, quality, and regulatory compliance. The role involves troubleshooting, data analysis, and driving continuous improvement across cGMP environments.

You will support technology transfer, scale-up, automation, validation, and training, reporting to the Director of Operations. This position requires a strong biomedical or process engineering background and hands-on biomanufacturing experience.