SUMMARY OF POSITION
Under the direction of the Maintenance Supervisor, the Maintenance Specialist is responsible to support all activities related to maintenance and technical support for commercial products directly linked to compliance and business continuity requirements. These activities include equipment optimization, preventive and predictive maintenance, calibrations, and corrective actions. Implements continuous improvement plans to ensure efficient, low downtime and compliant operations. The employee must ensure proper equipment maintenance in his/her area. Complete orders in the SAP system, ensure the necessary spare parts to complete maintenance metrics and perform corrective maintenance. Work directly with the supervisor to ensure low downtime and the department compliant.
1. Available to work extended or rotative shifts, weekends, and holidays.
2. Support in directing the maintenance activities (preventive, corrective, and calibrations) of the mechanics, electricians, and Instrumentation technicians in the Manufacturing areas.
3. Ensure critical equipment performance in all maintenance areas and improve maintenance activities.
4. Provide support to all maintenance technicians to assist with troubleshooting activities as a Subject Matter Expert. Ensure job plans are accurate and able to be safely executed.
5. Coordinates external services (if necessary). Support the continuous improvement programs to optimize the operations, reduce costs, and improve safety, quality, and customer service which include but are not limited to energy conservation, equipment efficiency, improved maintenance, and the implementation of corrective/preventive actions related to equipment and/or facilities.
6. Participate in the Operational/Engineering area weekly tier meetings.
7. Lead troubleshooting and problem-solving events, identify and resolve issues, identify root cause identification, and resolve deviations.
8. Collaborate with Operational Area and Supply Chain Management team members, set priorities, and schedule corrective/predictive maintenance that requires substantial machine downtime.
9. Maintains compliance with current Good Manufacturing Practices (cGMPs), environmental, safety, health, Local and Federal Labor, and industrial regulations. Ensures that equipment and facilities meet validation requirements. Ensures compliance with environmental permits for the Operational Area Assists in the coordination in case of an emergency.
10. Supporting the Maintenance Supervisor with the Stock Room improvement following the equipment reliability and business continuity.
11. Participate in revising and developing Standard Operating Procedures (SOPs), guidelines, and operational training for the Operational Area. Implementation of the CAPAs to prevent recurrences.
12. Maintain update metrics for preventive and corrective maintenance. Ensure the compliance of the mechanical, electrical maintenance, calibrations, or any other maintenance
13. Supporting maintenance areas such as manufacturing, utilities, and building & facilities activities with documentation for changes, incidences, deviations, or any compliance activity
14. Ensure areas compliance with housekeeping activities, safety, and quality audit walkthroughs.
15. Perform any other job related duties as required or that may arise in the future.
• Bachelor’s Degree in Engineering; Mechanical, Electrical or Chemical or Business Administration
• Minimum of two (2) years of professional experience, with knowledge in pharmaceutical, Engineering, or Manufacturing area process.
• Experience in maintenance management in pharmaceutical, medical device or regulated industries.
Licenses and/or Certifications
• Lean / Six Sigma Certification; Yellow, Green, or Black belt, preferred