Process Engineering Supervisor

Job Summary

This individual will be required to routinely partner with cross‑functional teams to lead continuous improvement projects and support the generation and maintenance of process documentation. They will actively participate in equipment and process qualifications and ongoing quality system audits. In addition to direct support responsibility of a manufacturing area, this role will manage several engineers in similar roles within the organization.

• Assist in updating and generating new Manufacturing, Quality and Maintenance process documentation and data systems.
• Assist with developing and participating in training for manufacturing and engineering personnel.
• Direct, lead and mentor engineers in direct support of manufacturing activities.
• Revise Standard Operating Procedure and Manufacturing Procedures to capture all necessary process, product, and regulatory requirements.
• Assist in developing and managing engineering changes.
• Participate in capital requisition proposals and projects.
• Maintain process maps and value stream maps.
• Assist with complaint investigations and resolution.
• Assist with developing rework protocols where appropriate.
• Participate in maintaining appropriate work environmental conditions and recommend facilities modifications where appropriate.
• Serve as Subject Matter Expert on manufacturing processes and flow.
• Identify and lead manufacturing improvements and cost reduction projects.
• Perform troubleshooting on new and existing process problems.
• Lead CAPA related efforts for the technology platform.
• Serve as primary owner for developing and managing engineering changes.
• Coordinate with Process Support and R&D as a team member for new technology transfer and development of new technology.
• Other duties as assigned.

• Bachelor’s degree in a related field preferred (Industrial Engineering, Biochemistry, Chemistry, Chemical Engineering, etc.).
• Relevant associate’s degree with greater than ten years relevant work experience, or no education with greater than ten years relevant work experience.
• Preferred experience in manufacturing diagnostic testing products/assays; sample extraction/testing laboratory experience including Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP); biochemical processes including enzyme‑substrate and antibody interactions; advanced data analysis utilizing statistical software such as Minitab; experimental design, process analysis and LEAN Six Sigma.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is regularly required to see, talk, and hear; frequently required to stand, walk, and sit for prolonged periods; use hands to handle or feel; reach with hands and arms; and occasionally lift and/or move up to 25 pounds.

Specific vision abilities required include close visual acuity (with or without corrective devices), depth perception, and color vision.

Work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.