Job Overview
Responsible for, coordinating, and optimizing all maintenance activities within a highly regulated medical manufacturing environment. This role ensures maximum equipment availability, reliability, and performance through the implementation of advanced maintenance strategies (TPM), technical talent development, and strict compliance with quality, safety, and environmental regulations (FDA, ISO, EHS).This position combines both strategic and operational responsibilities, driving the transition from a reactive maintenance model to a preventive and predictive approach, ensuring business continuity
Job Requirements
• Coordinate with high-level maintenance technicians, fostering a high-performance culture, operational discipline, and continuous improvement.
• Plan, execute, and control preventive, corrective, and predictive maintenance programs to ensure equipment reliability and uptime.
• Implement and sustain TPM (Total Productive Maintenance) methodologies, including autonomous maintenance, focused improvement, and loss analysis.
• Ensure compliance with applicable regulatory standards for the medical industry (FDA) and internal quality requirements.
• Implement and drive key maintenance KPIs (MTBF, MTTR, OEE, Planned Maintenance %) through data-driven decision-making.
• Root cause analysis (RCM), CAPA, NCs, implementation, and resolution of critical equipment failures.
• Support with maintenance resources including personnel, spare parts, tools, budget, and external vendors.
• Coordinate cross-functionally with Production, Engineering, Quality, and EHS to ensure operational continuity and regulatory compliance.
• Ensure proper technical documentation (maintenance procedures, records, and support for IQ/PRAF when applicable).
• Identify and implement continuous improvement opportunities in equipment performance and operational costs.
• Enforce compliance with safety standards including LOTO, work permits, and environmental requirements.
What your background should look like
• Minimum 2 years of experience in industrial maintenance, preferably in medical devices, pharmaceutical, or highly regulated industries.
• Proven experience working with specialized technical teams.
• Background in preventive and predictive maintenance program management.
• Experience with continuous improvement methodologies (TPM, Lean, Six Sigma is a plus)
• Bachelor’s degree in industrial maintenance, Mechanical, Electromechanical Engineering, Electronics, Mechatronic or any other engineering related to the position.