Process Engineer

• 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

• Opportunity to make a meaningful impact within a growing diagnostic company
• Collaborative, mission-driven team environment
• Competitive compensation and benefits

• Medical, dental, and vision insurance
• 401(k) retirement savings plan
• Company profit sharing program
• Paid time off, including vacation, holidays, and sick leave
• Paid Parental Leave Program