Maintenance Technician GMP-Pharmaceutical
The primary role of the Maintenance Technician III is to provide high end, complex and effective maintenance support to Manufacturing, Research, QC and laboratory operations. The ability to perform work safely and execute the maintenance program codes is paramount. The technician must identify, troubleshoot and repair problems in all areas of mechanical systems that occur in the facility. The technician must be able to troubleshoot, identify and remediate equipment issues. The technician performs preventive maintenance activities, provides on call services when required and is responsible of accurate GMP documentation.
- Responsible for maintaining all manufacturing equipment including formulation, filling and packaging equipment, and plant utility systems including, steam boilers, air compressors, heating, ventilating and air conditioning systems (HVAC), water for injection and general upkeep of the physical plant including clean rooms and building roofing
- Provide effective advanced trouble shooting support and utilization of equipment to diagnose malfunctions.
- Continuously maintains state of the art proficiency in facility and manufacturing equipment, automation and controls systems.
- Update SOP’s and/or the computerized maintenance management system (CMMS) as necessary to maintain maintenance procedure and accurate equipment historical records.
- Adhere to Good Manufacturing Practices (GMPs) in the execution of the work schedule and operational support
- Order parts and components for jobs as needed. Assists with development of a spare parts inventory for new and existing equipment.
- Review, modify, and write preventative maintenance and facility equipment standard operating procedures. Test new procedures for accuracy and completeness.
- Document repairs, adjustments, and replacement of equipment and/ or components per cGMP and CDC standards as well as in accordance with Revance procedures.
- implement improvements to improve efficiency and prevent equipment obsolescence.
- Provide after hours on call support.
- Coordinate with outside contractors.
- Support validation of equipment and system IQ, OQ, and PQ(s).
- Assist with technical training of new maintenance technicians. Assist other department with training on new equipment and/or building systems.
- Oversee work and paperwork submitted by maintenance and calibration vendors as required as well as assign tasks and provides direction.
- Redline existing drawings. Provide basis for new drawings via hand drawn diagrams and schematics. Assist in drawing updates by performing system walk downs with P&ID(s)
- AS Degree in an Engineering discipline plus 5 years of related experience or 8 years of related experience with HS Diploma or equivalent.
Minimum Experience Required:
- At least 3 years of experience in pharmaceutical, biopharmaceutical or other regulated industry.
KNOWLEDGE, SKILLS and ABILITIES:
- Advance knowledge of electrical and mechanical principals, including general calibration practices.
- Advanced ability to read and translate the information within mechanical and electrical schematics and P&ID process diagrams.
- General ability to read, write and speak English.
- Intermediate ability to read and interpret documents, such as safety rules, SOPs, operating and maintenance instructions and procedure manuals.
- Intermediate ability to write reports, justifications, procedures, work orders and PM descriptions.
- General knowledge of GMP(s) and CDC select agent regulations desirable.