Position Summary:
Primary Duties:
1. Performs, documents, and improves procedures and Preventative Maintenance Activities.
a. Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and Manufacturing Directions.
b. Ensures the most recent information related to maintenance and reliability is communicated and/or documented for compliance, history, and reliability.
c. Strive towards continuous improvement of Preventative Maintenance procedures in pursuit of failure prevention and increased efficiency.
2. Maintains/Operates (and as necessary troubleshoots) USP Water Systems & Autoclaves with minimal supervision within a team environment.
3. Performs corrective maintenance activities as necessary and in compliance with site documentation and change control requirements.
4. Champions root cause analysis and continuous improvement to equipment /systems driving toward increasing reliability and minimizing the incidence of unplanned downtime to production equipment.
Education, Experience and Skills
High School Diploma/GED and 7 years of maintenance experience focused on support of production
equipment required.
AAS degree and 5 years of maintenance experience focused on support of production equipment preferred.
Knowledge, Skills and Abilities:
1. Background in Operation, Maintenance & troubleshooting of electrical, hydraulic, pneumatic controls, valves, pumps, motors, steam components, AB PLC, cGMP and CMMS. Ability to read ladder logic, troubleshoot PLC’s, electrical systems, AC/DC drive systems, proficiency in machining, welding & fabricating a plus, strong mechanical skills and / or USP Water and Autoclave experience preferred.
2. Experienced in the operation of high speed, highly automated, production equipment (in a cGMP environment within the last 6 years desired).
3. Basic Computer Skills required; must be experienced and proficient in the use of: Email and Windows Operating Systems & Basic Microsoft Office tools (specifically Word & Excel)
4. Excellent documentation and communication skills (written & verbal).
5. Strong attention to detail with GMP experience including knowledge of change control, validation and commissioning process desired.
6. Ability to work successfully autonomously and as an active contributor on a team/shift.
7. Willingness to work towards driving improvement within and external to the department as a Maintenance & Reliability team representative
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