Maintenance Manager

Essential Duties Include: Supervision of Frederick Facilities process maintenance technicians / process mechanics, I&E / calibration technicians, and field service technicians. Oversees installation, troubleshooting, repair, preventive maintenance, calibration, and spare parts management of cGMP equipment and devices used in the manufacture of Active Pharmaceutical Ingredients (API) and implements policies to drive operational excellence in the areas of predictive maintenance. Supports utilization and design of cGMP production facilities including operational capacity, utility design, HVAC for controlled environments, control and monitoring along with design of equipment required for compliant safe manufacture of product. Oversees and manages troubleshooting of manufacturing equipment issues. Develops processes and implements solutions that drive continuous improvement. Responsible for management and support of QA related activities relevant to the Facilities team including electronic maintenance work records, calibration records, non-conformances / deviations, change controls, CAPAs, and participation in customer and agency audits. Responsible for management and support of EHS related activities relevant to the Facilities team including the hazardous area monitoring (LEL/O2) system, coordination of work in Class I Div I/II electrically classified areas, and Process Safety Management (PSM) compliance. Responsible for systems that are used for maintenance of cGMP equipment and instrumentation including the computerized maintenance management systems (CMMS) and all changes implemented. Managerial responsibilities include development of reports through coaching and training, responsible for scheduling, directing activities, budgeting, and hiring for department. DurationNot applicableRegionAmericasTravel RequiredOccasionalSecondary LocationsRequirements Qualifications Required: University degree or equivalent combination of education and or experience. 10+ years of equivalent experience in maintenance of equipment/facilities in a pharmaceutical and/or biologics area. 5+ years of equivalent experience in management within a cGMP production facility, including supervision and coordination of personnel responsible for process equipment troubleshooting, PMs, and calibration. Desired: Experience with maintenance and repairs of fluid handling and thermal control equipment (pumps, agitators, automated valves, piping systems, instruments, and temperature control module skids). Experience with electrical maintenance and troubleshooting of process and mechanical systems. Experience as owner of computerized maintenance management system (CMMS) software including Blue Mountain Regulatory Asset Manager (RAM), Maximo, SAP, or similar. Ability to read and interpret documents such as operating and maintenance instructions, Process and Instrumentation Diagrams (P&IDs), electrical and controls schematics, site drawings, equipment manuals, and safety procedures. Demonstrated communication skills, including verbal and written communication, in contact with vendors, internal customers, and employees. Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Knowledge of OSHA, PSM, Class I Div I/II electrically classified areas, lock-out tag-out, confined space, hot work permits, and standard EHS related work practice requirements. Ability to work in a dynamic and progressive environment. Exceptional people skills, technical knowledge and influential leadership ability. 3002383
Salary Range: NA
Minimum Qualification
11 - 15 years

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