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.

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 manageseveral engineers in similar roles within the organization.

Essential Duties and Responsibilities:

• 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 Operation and Manufacturing Procedures to capture all necessary process, product, and regulatory requirements
• Assist in developing and managing engineering changes
• Participates in capital requisition proposals and projects
• Maintains process maps and value stream maps
• Assists with complaint investigations and resolution
• Assists with developing rework protocols where appropriate
• Participates in maintaining appropriate work environmental conditions and recommends facilities modifications where appropriate
• Subject Matter Expert on the manufacturing processes and flow
• Identify and lead manufacturing improvements and cost reduction projects
• Perform troubleshooting on new and existing process problems
• Assist with developing and participating in training for manufacturing personnel
• Revise Standard Operation and Manufacturing Procedures to capture all necessary process, product, and regulatory requirements
• Lead CAPA related efforts for the technology platform
• Primary owner for developing and managing engineering changes
• Participates in capital requisition proposals and projects
• Maintains process maps and value stream maps
• Coordinates with Process Support and R&D as a team member for new technology transfer and development of new technology
• Assists with complaint investigations and resolution
• Assists with developing rework protocols where appropriate
• Participates in maintaining appropriate work environmental conditions and recommends facilities modifications where appropriate
• Other Duties as assigned.

Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience: Bachelor's degree in related field preferred (Industrial Engineering, Biochemistry, Chemistry, Chemical Engineering, etc.) Relevant associate's degree and greater than ten years relevant work experience, or no education and greater than 10 years relevant work experience. Preferred experience in the area of:

• 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

Physical Demands
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. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to see, talk and hear. The employee is frequently required to stand, walk and sit, for prolonged periods of time. The employee is required to use hands to handle or feel; reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close visual acuity (with or without corrective devices), depth perception and color vision.

Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.