SUMMARY The Automation Maintenance Technician is responsible for maintaining, troubleshooting, repairing, and improving automated manufacturing and facility systems used in medical device and pharmaceutical production. Equipment may include PLC-controlled machinery, robot controllers, vision systems, motion control systems, automated assembly equipment, packaging systems, part feeders, and associated electrical, pneumatic, and mechanical components. The position supports equipment reliability, preventive maintenance, continuous improvement initiatives, and validated manufacturing operations while working in GMP-controlled and cleanroom environments. This position reports to the Facility & Equipment Manager and collaborates closely with Operations, Engineering, Quality, Validation, and Manufacturing personnel.

ESSENTIAL RESPONSIBILITIES A

qualified candidate must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Troubleshoot electrical, mechanical, pneumatic, servo, robotics, PLC, HMI, and vision system issues to minimize downtime and restore equipment to qualified operating conditions. Perform scheduled preventive and predictive maintenance activities on manufacturing and facility equipment in accordance with approved procedures and maintenance plans. Maintain accurate maintenance records, work orders, asset information, and preventive maintenance schedules within the Asset Management/CMMS system. Effectively communicate maintenance schedules with management. Accurately document maintenance activities, troubleshooting results, component replacements, deviations, and corrective actions within approved quality and maintenance systems. Ensure all documentation complies with Good Documentation Practices (GDP), data integrity requirements, and applicable quality system procedures. Communicate with 3rd party vendors or contractors as needed for some maintenance tasks. Support equipment commissioning, qualification, validation, and change control activities as required. Participate in investigations, root cause analysis, corrective actions (CAPA), and continuous improvement initiatives related to equipment reliability and manufacturing performance. Assist on an as needed basis with building maintenance. Troubleshoot electrical, mechanical, pneumatic, servo, robotics, PLC, HMI, and vision system issues to minimize downtime and restore equipment to qualified operating conditions. Perform scheduled preventive and predictive maintenance activities on manufacturing and facility equipment in accordance with approved procedures and maintenance plans. Maintain accurate maintenance records, work orders, asset information, and preventive maintenance schedules within the Asset Management/CMMS system. Effectively communicate maintenance schedules with management. Accurately document maintenance activities, troubleshooting results, component replacements, deviations, and corrective actions within approved quality and maintenance systems. Ensure all documentation complies with Good Documentation Practices (GDP), data integrity requirements, and applicable quality system procedures. Communicate with 3rd party vendors or contractors as needed for some maintenance tasks. Support equipment commissioning, qualification, validation, and change control activities as required. Participate in investigations, root cause analysis, corrective actions (CAPA), and continuous improvement initiatives related to equipment reliability and manufacturing performance. Assist on an as needed basis with building maintenance.

EXPECTATIONS

Respond to equipment issues in a timely manner to minimize manufacturing downtime and support production schedules. Maintain compliance with GMP, safety, environmental, and company policies at all times. Demonstrate professionalism when interacting with auditors, customers, vendors, and regulatory agencies as required Work independently with minimal direct supervision. Self-motivated. Participate in team building, training, and department communications. Respond to equipment issues in a timely manner to minimize manufacturing downtime and support production schedules. Maintain compliance with GMP, safety, environmental, and company policies at all times. Demonstrate professionalism when interacting with auditors, customers, vendors, and regulatory agencies as required Work independently with minimal direct supervision. Self-motivated. Participate in team building, training, and department communications.

QUALIFICATIONS

Below are the guidelines for education, knowledge, skill, and/or abilities needed to perform each essential duty satisfactorily. Reasonable accommodation will be considered for individuals who are unable to meet the required qualifications. Associate degree in electrical engineering, mechanical engineering, engineering technology with a concentration in Robotics or other. 5 - 7 years of experience in a comparable industry/position. Demonstrates strong technical writing skills; proficient in drafting clear, concise, and grammatically correct SOPs and documentation in compliance with GMP standards. Previous experience working in a regulated environment. Basic understanding of root cause analysis techniques. Basic understanding of good manufacturing practices (GMP) per FDA guidelines. Basic knowledge of PLCs. Experience troubleshooting robotics/automation. Strong problem-solving skills. Ability to deal with ambiguity and work independently.

Wage Range:

$31-$37 per hour Associates or better in Mechanical Engineering or related field. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.