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The Facilities Director, reporting to the Plant Manager, provides oversight, planning, and management for facility operations, maintenance and improvements.
Establish operational objectives and assignments to ensure effective management of facility operations and maintenance programs including management of outside service providers, energy conservation, asset management, resource planning, and identification and use of industry best practices and procedures. Lead and manage a high performance organization that is customer focused and committed to the success of the department and organization.
Provide oversight for all facility-related operations to include general facility maintenance, up keep and maintenance of GMP cleanrooms, change controls, calibration, and preventive maintenance.
Provide guidance and direction on projects involving alterations to facilities support systems and critical utilities.
Assure compliance to cGMP requirements, adhere to Standard Operating Procedures (SOPs), and generate change controls as necessary.
Oversee and maintain computerized Building Management System (BMS), and respond to all critical alarms as they relate to temperature, relative humidity, and differential pressure.
Schedule and coordinate calibration and preventive maintenance activities for all utilities and equipment/instrumentation in accordance with cGMP.
Maintain updated equipment history files, and participate in facility-related audits as needed.
Review cGMP validation documentation for systems, equipment & manufacturing processes, including validation plans, protocols and reports.
Performs management functions including performance management, staff training and development.
Develop key departmental metrics and generate and submit reports to senior management.
BS in an engineering-related field
2-4 years of hands-on equipment calibration or maintenance related experience. (Vocational training in a related field may be substituted for years of experience); biotechnology or pharmaceutical production plant experience preferred.
Ability to read electrical and plumbing schematics; maintain and repair electrical/mechanical fixtures; troubleshoot control malfunctions on incubators, autoclaves, centrifuges, refrigerators, freezers.
Experience with Building Management software strongly preferred
Proven experience in installing, maintaining, troubleshooting, repairing and replacing building equipment and systems.
Self-motivated, high energy level and a positive outlook coupled with a “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
Ability to quickly adapt in a constantly evolving environment
Possess excellent interpersonal skills, both communication and written. Must be able to communicate effectively with all members of management and staff.