Production Line Mechanic

Responsibilities

• Maintain a safe working environment, leading safety initiatives, and working safely.
• Perform preventative maintenance inspections/repairs and document additional repairs needed.
• Daily operations performed in controlled cleanroom environment with full gowning requirements/procedures in compliance of GMP standards.
• Remove/repair/adjust/install assemblies (e.g., pumps, agitators) using manual and powered tools.
• Inspect and adjust equipment (e.g., valves, mixer motors, agitators, torque wrenches, crimping tools, PSV’s PSE’s and drives).
• Troubleshoot root cause of machine problems (e.g., excessive vibration or temperature, abnormal noises, and poor performance).
• Provide accurate, complete, and detailed Work Order documentation on both paper copy (when required) and in CMMS system.
• Maintain 100% compliance with self-study training requirements.
• Communicate effectively with operations supervisors on any process problems.
• Lay out/measurement/fabrication and installation of short sections of pipe necessary to make repairs.
• Repair/replacement of corroded, damaged, or plugged pipe including screwed, and flanged.
• Fabricate parts (e.g., brackets, stands, guards, insulation boxes) using shop equipment.

Requirements

• Education Level: High School Diploma/GED
• Experience: 5-7 years of mechanical and electrical maintenance experience in GMP-regulated cleanroom environments.
• Certifications: N/A
• Licenses: Valid Driver's License

Skills

• Ability to read and interpret mechanical & electrical prints/schematics
• Associate’s degree or Technical Certificate in a mechanical discipline, or equivalent experience
• Applicable military service training may be an acceptable alternative
• Demonstrated ability to work safely in a participative, team-oriented environment
• Experience working with Robotics
• Knowledge of parenteral equipment and manufacturing operations
• Low voltage/electrical troubleshooting under 1000 V
• Influential leadership skills with the ability to mentor and work independently while adapting to changing priorities
• Strong interpersonal, communication, and customer service skills
• Excellent organizational skills and attention to detail
• Proficiency in Microsoft Word and Excel
• Expertise in production processes, equipment, CMMS, and troubleshooting
• Familiarity with HOLD/MAP processes, change control, and observation investigations
• Ability to follow written procedures, read/interpret mechanical and electrical prints/schematics
• Familiarity with maintenance, shop tools and equipment (machining and welding capability a plus)
• Willingness to work outside primary craft as required
• Experience in equipment/process troubleshooting and relevant GMP manufacturing