Job Purpose: The Facilities and Maintenance Manager will provide support to the VP of Operations in maintaining site facility, production equipment and utility operations for our manufacturing, laboratory, and front office operations. The ideal candidate will have broad knowledge of all aspects of facilities maintenance related to the pharmaceutical industry to include but not limited to; utilities, computerized maintenance management system, and building automation systems. They will have basic to intermediate knowledge of industrial electrical & mechanical maintenance. With a solid work history in a GMP environment.
Summary of Key Responsibilities:
Works closely with Quality, Engineering and Operations groups to ensure strict compliance with GMP / GLP guidelines, specifically to ensure that the facility and equipment is maintained in GxP compliance.
Manages all service providers/vendors and contracts executing facility and maintenance activities.
Directs all corrective and preventative maintenance on facility, production, and utility equipment (GMP & non-GMP). Candidates with prior experience working on USP water, HVAC, and refrigeration systems are especially desirable.
Drafts and executes efficient maintenance job plans, procedures, and work instructions for the utility, electrical and power equipment at the site.
Participates in the continuous improvement efforts within the site Maintenance Program.
Responsible for the 24-hour response to facility and utility alarms throughout the facility.
Functions as the CMMS owner and administrator.
Functions as Access control owner
Manages the company’s computerized maintenance management system (CMMS).
Provides support for start-up, commissioning and turnover of new facility / utility systems.
Supports other departments/areas to troubleshoot, test, repair, and optimize, equipment as need
Uses tools and software (CMMS, BAS, PLCs) required to resolve equipment and process issues within all technical competencies.
Assists with workload as needed to ensure schedules are held.
Other duties as to ensure the site is compliant with Federal, State and Local regulations.
Required Qualifications and Skills:
7+ years relevant GMP / industry experience OR an associate’s degree with 5+ years’ relevant GMP / industry experience. A bachelor’s degree in engineering or technical field is a plus.
Working knowledge of the National Electric Code (NEC), preferred.
Proven knowledge of facility maintenance practices and principles.
Strong organizational and planning skills required.
Experience and knowledge of maintenance principles within a cGMP Pharmaceutical manufacturing environment.
Knowledge of PLC, and/or Building Automation Systems (BAS), and/or HVAC control systems, preferred.
Proven knowledge of a Computerized Maintenance Management System (CMMS), preferred.
Ability to problem solve and troubleshoot systems in an industrial environment required.
Interpersonal effectiveness and communication skills (written and oral) are required to interface across management levels and departments.