Leads all maintenance functions of production equipment in the assigned area. Work includes routine inspection and repair or replacement of defective or faulty parts on machines and related equipment.
All work to be performed in such a matter to ensure good workmanship with minimum delay. This position is expected to take a proactive role in supporting the mfg team, provide internal customer support, and build a high level of trust with internal customers and QA / Mfg personnel.
In addition, this position is expected to identify and execute tasks that enhance the ability of the team to provide an added value line maintenance service for the site and provide guidance and direction on maintenance technical issues, as well as assist in providing innovative, creative, effective, and long-
term solutions related to mfg line maintenance and repair.
1. Maintain all assigned test equipment and assuring equipment is in calibration
2. Perform equipment preventative maintenance, troubleshooting, and repair duties
3. When necessary, coordinate maintenance / repair of equipment between cross-functional operation and 3rd Parties
4. Ensure timely turn-around time on all equipment maintenance and repair services
5. Generate and maintain appropriate work-related records, such as maintenance work orders, IQ / OQ reports, PM schedules & checklists, and the like.
6. Assist in maintaining equipment asset data
7. Write and update procedures to ensure efficiency, standardization, and accuracy or repair / maintenance services
8. Work with production on a daily basis to coordinate appropriate course of action to maximize uptime and quality performance of respective area.
9. Use tools and equipment to repair or modify parts and equipment
10. Supports engineers in equipment or process validation studies.
11. Understand, troubleshoot, and repair equipment, such as :
1. Technical school education or equivalent education / experience.
2. Strong background in machine maintenance and troubleshooting skills.
3. Knowledge and experience working with machine control systems, including PLC’s (Panasonic, AB, Mitsubishi, etc.), servo controls, and Variable Speed Drives, including vision systems
4. Good understanding of GMP’s with experience in a med device mfg environment
5. 3-5 years related experience
6. Medical device industry experience preferred
7. Experience with reading and preparing technical documentation a must
8. Experience with quality management systems