Lead Maintenance Technician

Job Scope

The Lead Maintenance Technician is primarily responsible for leading highly diversified duties to install, troubleshoot, repair and maintain production equipment according to safety, predictive and productive maintenance systems and processes to support the achievement of the site's business goals and objectives.

Duties And Responsibilities

• Lead, Administer, and execute a Preventative Maintenance Program for Production Equipment
• Maintain a professional manufacturing environment for Medical Device Manufacturing
• Responsible for coordination of routine and non-routine maintenance of all cGMP and non cGMP equipment and systems
• Serve as a contact and escalation point for equipment down-time issues outside of standard business hours
• Provide emergency/unscheduled repairs of production equipment during production and performs scheduled maintenance repairs of production equipment during machine service
• Read and interpret equipment manuals and work orders to perform required maintenance and service
• Troubleshoot and Diagnose Production Equipment problems, replace or repair parts, test and make adjustments
• Perform regular preventative maintenance on machines, equipment to maintain satisfactory equipment up-time
• Able to read, write and interpret technical documents and instructions, electrical and mechanical drawings, equipment blue prints and piping and instrumentation drawings (P&ID)
• Maintain proper Equipment Documentation (Device Master Equipment Files) and maintain event records
• Perform mechanic skills including, but not limited to, mechanical, electrical, pneumatic, hydraulic, troubleshooting and repair of production machines
• Escalate difficult/complex issues when necessary
• Wiring and Mechanical Assembly of Production fixtures
• Provides team leadership and provides assistance to other technicians with support tasks that require considerable judgment and initiative
• Aids in Facilities maintenance on an as-needed basis
• Ensures adherence to current Good Manufacturing Practices cGMP and Standard Operating Procedures (SOPs) requirements in performing above duties
• Interfaces/coordinates with departmental management to meet departmental maintenance objectives
• Aids in overseeing the safety and appearance of manufacturing equipment
• Provides guidance and resolution to technical or operational problems
• Develops, orders, and maintains spare parts inventory to minimize downtime
• Interacts with various internal and external groups to facilitate the resolution of manufacturing equipment mechanical problems
• Ability to work flexible hours and overtime

Experience, Education & Qualifications

• H.S. Diploma required
• Associate's Degree in Mechanical or Engineering field or technical degree/trade certificate, and more than 4 years related experience preferred
• 3+ Years Experience in Manufacturing Assembly or Assembly Equipment with hydraulics, pneumatics, mechanics, electrical and PLC troubleshooting and repair required
• 1+ Years Experience in a GMP and/or FDA regulated environment required
• 3+ Years Experience working independently in a fast-paced environment with rapidly changing priorities required

Training And Skills

• Hands-on electro-mechanical-mechanical assembly and troubleshooting experience (High proficiency)
• Experience with basic machine tools and fixturing desirable (mill, lathe, hand tools, etc.) (High proficiency)
• Experience in advanced automated processes (High proficiency)
• Great attention to detail and commitment to excellence in review and work product (High proficiency)
• Ability to write detailed repair reports and records activities in the ERP system (High proficiency)
• Must have good mathematical skills, including basic algebra, to calculate electrical/electronic equations as needed (High proficiency)
• Experience working in a regulated environment (FDA, etc.) is desirable (High proficiency)
• Ability to read and follow detailed written instructions and have good verbal/written communication skills (High proficiency)
• Good computer skills desired. Experience with Microsoft Excel required (High proficiency)
• Thorough understanding of machine component design (High proficiency)
• Highly organized with proven time management and prioritization skills (High proficiency)
• Ability to work independently and with minimal supervision (High proficiency)
• Ability to excel in pressure situations to meet tight deadlines (High proficiency)
• Applicable knowledge of cGMP regulations with respect to manufacturing and maintenance best practices (High proficiency)
• Ability to lead, direct, and coach other maintenance technicians (High proficiency)

Travel Requirements

10% Travel may be required