Key Responsibilities:
• Organize and manage daily work to keep the GMP plant, warehouse, QC lab and PD lab in a smooth operational status. Resolve issues in a timely manner.
• Manage external contractors and suppliers to reliably support facility/utility operations
• Effectively use CMMS/EMS for maintenance operations; help with improvement with systems
• Perform Daily walk-throughs to proactively identify issues and seek continuous opportunities to improve efficiency and reduce cost
• Respond to afterhours urgent facility problems and resolve them
Requirements:
• Minimum of 6 years of experience of facility & utility maintenance under GMP environment.
• Experience with BMS (Building Management System) and EMS (Environmental Monitoring System)
• Experience with utility systems, clean air, pharmaceutical gasses, HVAC systems
• Experience maintaining grade B/C/D clean rooms
• Solid mechanical and engineering skills to troubleshoot HVAC, Boiler, Chiller, and Compressed air systems. Knowledge with Liquid Nitrogen storages a plus.
• Responsible for authoring and maintenance of standard operating procedures (SOP) and equipment forms/logbooks for the department
• Experience working within a CMMS (Blue Mountain, SAP, Maximo, etc.) and managing PM/Corrective work orders and associated documentation.
• Experience handling deviations, CAPAs, and Change Controls associated with facility or engineering
• Ability to support internal and external audits.
• Effective communication and organizational skills.
• Flexibility to perform various tasks and ability to prioritize based on business needs.
• Ability to thoroughly review controlled documentation for clarity and traceability.
EDUCATION/EXPERIENCE
• Associates Degree required. Batchlor’s degree preferred. Minimum of 6 years of experience maintaining facility and utility of GMP plant.