Lead Maintenance Engineer (Medical Device)

Job Summary

The Lead Manufacturing Maintenance Engineer is a senior level mechanical position, that primarily performs complex mechanical and electrical repairs to automated and semi-automated machinery. Specializing in detailed diagnostics of machine issues, utilizing schematics and detailed knowledge of mechanical principles.

Key Accountabilities

• Subject matter expert in all mechanical and electrical systems, related functions and automated machines, including HVAC systems, and lyophilizing equipment.
• Oversee and carry out the diagnoses and repair of automated machinery.
• Utilize diagnostic tools and techniques to identify and resolve complex mechanical problems.
• Direct the work of other mechanics, provide guidance, training, and support, and ensure tasks are completed efficiently and to a high standard.
• Develop and implement preventative maintenance schedules to minimize downtime and ensure equipment reliability.
• Ability to lead a team of mechanics.
• Carry out work safely per OSHA regulated guidelines, and established safety procedures.
• Ensure compliance of FDA, ISO, OSHA, and GMP regulations and standards in regard to maintenance actions.
• Establish and maintain departmental SOPs, PM Task Lists, Forms and Attachments and ensure compliance with Werfen’s controlled document process.
• Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs.
• Maintain accurate records of maintenance and repairs, prepare reports, and communicate effectively with management and other team members.
• Work to identify improvements for cost and manual labor reduction, and to improve process/equipment yields; work with management to implement identified improvements.
• Support and drive change within the operation by establishing partnerships with peers, cross functional stakeholders, assigned staff and shop floor colleagues to align their actions with the process improvement efforts.
• Support daily production activities and goals; continuously work to ensure mechanical performance of equipment that supports timely release of product and avoids back orders.
• Support the installation, qualification, and validation of new equipment and processes.
• Support the engineering staff, R&D, and manufacturing operations personnel as required.
• Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures, and processes.
• Make recommendations for efficiency improvements, equipment purchases, and facility upgrades.
• Interface with regulatory agencies for site audits if called upon.
• Other duties as assigned.