Director, Maintenance

 A brief overview

The Director of Maintenance is responsible for the coordination and direction of facility and equipment maintenance. This position will manage the maintenance programs to ensure full compliance with GMP requirements. The Director will be responsible for development and updating programs including preventative maintenance, capital installation projects, energy conservation programs, Computerized Maintenance Management system, supervision of direct reports, and facility programs support.

 

What you will do

• Ensure full compliance to policies and guidelines
• Proactively work to identify equipment replacement needs
• Develop and implement changes to the Preventive Maintenance (PM) and Predictive Maintenance (PdM) Programs to ensure full compliance
• Prepare budgets for the Maintenance Engineering department
• Maintain costs within the budgeted expenses within all areas of control
• Work with Quality, IT, Engineering and Production Departments to develop and maintain alarm logging systems and trending requirements and provide guidance to ensure continuous monitoring and system improvements
• Ensure that federal, state, and local regulations, including GMP and EHS regulations, are complied with as evidenced by internal audits and inspections from Government Agencies
• Train, guide, and evaluate employees in the interpretation of company policies, goals, and objectives for the company sites
• Maintain an adequate workforce to support present needs and plan for departmental requirements in the future
• Promote good relationships within the department and with other departments within the company
• Coordinate with all departments in technical matters dealing with plant infrastructure, instruments and equipment
• Maintain and troubleshoot key equipment and ensure continuous and smooth operation
• Coordination of maintenance, engineering, and construction activities
• Cost control of plant related activities, contractors and utilities
• Direct recurring calibration/certification of equipment and instruments
• Advise executive management and department managers about improvements, acquisition of buildings and equipment
• Coordinate and manage building monitor systems, providing system alarms and status through Ethernet solutions
• Manage/administrate the Computerized Maintenance Management System
• Monitor all facility and production equipment and/or service as per compliance with in-house Standard Operating Procedures
• Manage Preventative Maintenance (PM) program; includes schedules, and non-routine repairs
• Maintain equipment history files to track maintenance, equipment manuals, and supporting documentation
• Provide engineering assessment, user functional requirements and estimates for equipment, utility or facility upgrades
• Participate as a key member of the management team
• Responsible for troubleshooting of equipment/facilities; requires 24 hour phone monitoring and possible weekend and after hours response
• Manage contract service providers; includes training, scheduling, coordination, external SOPs, and documentation of all work in accordance with GMP requirements
• Must have strong negotiation skills and significant experience in interacting with contractors
• Submit annual budget proposal to management while taking responsibility for department budget control
• Review/modify in-house Standard Operating Procedures
• Train department members in safety and job related functions
• Supervise regulatory and safety requirements related to departmental functions
• Travel will be required between Vista, Ca. and Torrance, Ca facilities

Qualifications

• Bachelor's degree in science or engineering
• 10+ years relevant experience
• Experience in facility and equipment maintenance, troubleshooting, and engineering
• Experience with equipment and instrument qualification and calibration
• Experience with peptides (preferred)
• Technical knowledge of facility equipment, analytical instrumentation, process equipment, and all associated applications
• Ability to manage and lead a team
• Proficiency with technical writing
• Working knowledge of cGMPs as they relate to a pharmaceutical manufacturing facility
• Detail oriented with the ability to troubleshoot and resolve equipment problems
• Proficient in reading schematics and diagrams as well as other written materials
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven wo