ASSOCIATE DIRECTOR OF FACILITIES ENGINEERING
The main responsibilities will include but not limited to follows:
• Overall responsibility for maintaining and operating the GMP Production utilities to include fifteen (15) HVAC units, Utility Systems to include; RODI make-up and Distribution, CO2 System, Compressed Air Make-Up and Distribution, Process Gases, and Vacuum System and General utility systems to include Building Management System (BMS), Equipment Monitoring System, Boilers, Chillers, and Waste Management Systems.
• Provide oversight for all facility, and engineering-related operations to include general facility maintenance, GMP, GCLP, and R&D related laboratories, Change Controls, Calibration, Preventive Maintenance, and vendor qualification and training, and Materials Management functions.
• Provide oversight to Operational Groups to include Facilities, Facilities-Engineering, Materials Management, and Warehousing Operations. Maintain Staffing levels in alignment with Business and Production needs.
• Provide guidance and direction on projects involving alterations to facilities support systems and critical utilities.
• Maintain up-to-date facility-related piping and instrument drawings, equipment drawings, and GMP process-related drawings.
• Monitor operations of facility support systems and critical utilities, make recommendations to improve efficiencies and reliability, for a 50-week per year critical operation, and an annual 2-week per year facility shutdown.
• Assure compliance to cGMP requirements, adhere to Standard Operating Procedures (SOPs), and generate change controls as necessary.
• Serve as project leader for all facility related GMP activities. Maintain timeline and budget.
• Oversee and maintain computerized Building Management System (BMS), and respond to all critical alarms as they relate to temperature, relative humidity, and differential pressure for the areas within the GMP envelope.
• Schedule and coordinate calibration and preventive maintenance activities for all manufacturing –related 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.
Knowledge and Experience Required:
• BS, or MS in an engineering-related field or an equivalent trade school field of study.
• 5-10 years of hands-on equipment calibration or maintenance related experience. (Vocational training in a related field may be substituted for years of experience); biotechnology experience preferred.
• Requires knowledge of facility HVAC systems, RODI systems, Compressed Air systems, and Vacuum Systems, Equipment Monitoring Systems, Boilers, Chillers, and BAS systems.
• Ability to read electrical and plumbing schematics; maintain and repair electrical/mechanical fixtures; troubleshoot control malfunctions on incubators, autoclaves, centrifuges, refrigerators, freezers.
• Proven experience in installing, maintaining, troubleshooting, repairing and replacing building equipment and systems.
• Proven leadership ability and skills.
• Must be able to lift up to 50 lbs
• Possess excellent interpersonal skills, both communication and written. Must be able to communicate effectively with all echelons of Management and staff.
• Intermediate computer skills using MS Office (Word, Excel) and LOTUS Notes preferred.
Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.
Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that “negotiable” is neither salary nor requirements. Salary commensurate with experience.