Collaborate closely with Manufacturing Engineers and production teams to support and enhance manufacturing operations. Responsibilities include troubleshooting equipment and process issues, documenting fixtures, and updating process documentation. Assist with projects such as new product introductions, fixture and process development, process validations, and continuous improvement activities.
Main Job Responsibilities
Production
Act as the first responder for troubleshooting processing, scrap, or yield issues on the manufacturing floor to support build schedules and ensure on-time delivery.
Respond to line calls professionally, safely, and promptly.
Identify, lead, and support continuous improvement activities.
Document testing and troubleshooting results.
Identify and improve safety issues within production areas.
Maintain and improve 5S practices throughout assigned work areas.
Follow required lockout/tagout procedures and all other safety requirements.
Prepare and set up equipment in collaboration with Manufacturing Engineers and Maintenance.
Engage in the Value Stream structure and process to support Value Streams.
Sustain the daily operation of production machines and fixtures with the goal of zero downtime.
Monitor clean rooms for needed equipment repairs and submit work orders as needed.
Collaborate with Maintenance Technicians, Engineers, and Operators to identify and resolve equipment issues promptly.
Engineering
Assist Manufacturing Engineers in developing processes, including equipment specification, fixture design and development, installation, testing, debugging, and troubleshooting.
Assist or lead installation qualifications of equipment, fixtures, or tooling (IQ), accurately documenting results.
Assist or lead the execution of operational qualifications (OQ), including data collection and accurate documentation of results.
Assist or lead the execution of production process qualifications (PQ or PPQ), including data collection and accurate documentation of results.
Assist or lead the disposition of non-conforming materials (NCR).
Assist or lead Corrective and Preventative Actions (CAPA) using problem-solving methodologies and Root Cause Analysis (RCA) tools.
Other
Follow all GMP and SOPs as defined by company policies, practices, and procedures to ensure compliance with FDA and ISO regulations and quality standards.
Communicate with suppliers, equipment builders, or customers as required to resolve equipment issues.
Perform other duties as assigned.
Position Requirements
Knowledge/Education:
Associate Degree in Engineering Technology or a related field, or an equivalent combination of education and experience.
Advanced technical training or certification preferred.
Job Experience:
Hands-on technical experience in a manufacturing environment preferred.