Job Description

Job Description

The Sr. Maintenance Technician is responsible for direct support of all USP Water Systems & Autoclaves at the bioMerieux, Inc. Durham Manufacturing Facility. This role involves performance of Preventive and Corrective maintenance by mechanical and electrical troubleshooting of specialized equipment that have a direct impact to manufacturing and product quality. The candidate is also required to be an active contributor to failure root cause analysis, equipment / system / process improvement, and take an active leadership role in the continuous improvement of departmental systems and infrastructure. Candidate will also be required to work autonomously in a GMP environment in addition to being an active contributor to 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. 

Primary Duties:

1. 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.
2. Maintains / Operates and troubleshoots USP Water Systems and Autoclaves with minimal supervision within a team environment.
   • Ensure the most recent information related to manufacturing and maintenance is communicated and/or documented for compliance, history, and reliability.
3. Performs corrective maintenance activities as necessary and in compliance with site documentation and change control requirements. 
   • Ensure that the manufacturing equipment meets and exceeds the Overall Equipment Effectiveness (OEE) goals determined by World Class Manufacturing standards to support business demands.
4. Champion root cause analysis and continuous improvement to equipment/systems driving toward increasing reliability and minimizing the incidence of unplanned downtime to production equipment.
   • Ensure manufacturing line is operating at optimum level for a GMP environment in a safe manner while meeting production goals.

Direct support of USP Water & Autoclaves operating on a 24/7 2-2-3 schedule.

• Minimum of 100 million bottles manufactured annually

~ 400,000 bottles manufactured per business day

Education, skills and experience:

1. High School Diploma and 7 years of maintenance experience on electro-mechanical systems required
2. 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.
3. Experienced in the operation of high speed, highly automated, automated mechanical and electrical systems (in a regulated environment within the last 6 years preferred).
4. Basic Computer Skills required; must be experienced and proficient in the use of Windows operating system, MS Office (Word, Excel, Outlook)
5. Excellent documentation and communication skills (written & verbal).
6. Strong attention to detail and GMP experience.
7. Ability to work successfully autonomously, as an active contributor on a team/shift.
8. Demonstrated leadership behaviors and skills and a willingness to work towards driving improvement within and external to the department, as a SSO team representative.

Preferred:

1. Associates degree in electronics technology or related field + 5 years maintenance experience focused on support of production equipment.
2. Minimum 3 years’ experience working in a cGMP/Regulated environment.
3. Proficiency in machining, welding, and fabricating.
4. Knowledge of change control, validation, and commissioning processes.

Leads by example. Mentors peers in maintenance and production areas by demonstrating the behaviors of being a self-starter who is organized, detailed, conscientious, and ambitious.

Models behaviors such as being a team player with a positive attitude, approaching projects/tasks with a sense of ownership, and developing and improving the skill level and behaviors of others.

Performs and documents preventative maintenance activities with an eye towards constant improvement of existing procedures/processes.

Operates and effectively troubleshoots high speed PLC based manufacturing equipment. Troubleshoots AC/DC drive systems.

Performs documentation requirements in a cGMP compliant manner in accordance with applicable Quality Policies.

Responsible to follow all site Safety Policies/OSHA policies including requirements as related to personal protection equipment as needed to perform routine and non-routine duties.

Performs documentation requirements in a cGMP compliant manner in accordance with Quality Policies.

Takes an active/leading role in continuous equipment improvement as well as infrastructure improvement toward the implementation of sustainable reliability based maintenance program.

  Ability to work effectively as part of a team in addition to autonomously as required.

  Proficient in the use of computers and Microsoft Office tools (Word & Excel).

Effectively communicates within the team both verbally and written.

Interfaces with other site departments to achieve common goals.

High level understanding of equipment, processes and products.

Able to read electrical schematics, P&IDs, and shop drawings.

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