The Maintenance Technician 3 is responsible for direct support of all manufacturing process equipment at the Client. Durham Manufacturing Facility. This role involves performance of Preventive and Corrective maintenance by mechanical and/or electrical troubleshooting of specialized and highly automated process equipment. The candidate is also required to be an active contributor to failure root cause analysis, continuous improvement of departmental systems and infrastructure, and the Production Maintenance team. These responsibilities have the ultimate goal of supporting production to achieve output goals by maintaining the equipment to perform as designed thereby delivering a quality product.
- Performs, documents, and improves procedures and Preventative Maintenance Activities.
- Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and Manufacturing Directions.
- Ensures the most recent information related to maintenance and reliability is communicated and/or documented for compliance, history, and reliability.
- Strive towards continuous improvement of Preventative Maintenance procedures in pursuit of failure prevention and increased efficiency.
- Maintains / Operates (and as necessary troubleshoots) highly automated mechanical and electrical systems with minimal supervision within a team environment.
- Performs corrective maintenance activities as necessary and in compliance with site documentation and change control requirements.
- Ensures that the automated mechanical and electrical systems meets and exceeds the Overall Equipment Effectiveness (OEE) goals determined by World Class Manufacturing standards to support business demands.
- Ensures manufacturing line is operating at optimum level for a GMP environment in a Safe mode while meeting production goals.
- Champion root cause analysis and continuous improvement to equipment/systems driving toward increasing reliability and minimizing the incidence of unplanned downtime to production equipment.
Experience
- Minimum 7 years of experience in electrical and mechanical high speed manufacturing maintenance or minimum 7 years of troubleshooting and repairing mechanical and electrical systems required.
- Minimum 3 years’ experience working in a cGMP/Regulated environment desired.
- Ability to read ladder logic, troubleshoot and repair PLC’s, electrical systems, AC/DC drive systems, and mechanical systems. Proficiency in machining, welding, and fabricating a plus.
- Experienced in the operation of high speed, highly automated, automated mechanical and electrical systems (preferably in a regulated environment within the last 6 years desired).
- Basic Computer Skills required; must be experienced and proficient in the use of:
- Email
- Windows Operating Systems
- Basic Microsoft Office tools (specifically Word & Excel)
- Excellent documentation and communication skills (written & verbal).
- Strong attention to detail and GMP experience (including knowledge of change control, validation, and commissioning processes) desired.
- Ability to work successfully autonomously, as an active contributor on a team/shift.
- Demonstrated leadership behaviors and skills and a willingness to work towards driving improvement within and external to the department, as a Maintenance & Reliability team representative.
Working Conditions and Physical Requirements
Ability to remain in stationary position, often standing, for prolonged periods. Ability to ascend/descend stairs, ladders, ramps, and the like. Ability to wear PPE correctly most of the day. Ability to operate heavy machinery. Ability to adjust or move objects up to 50 pounds in all directions.