Equipment Specialist

• Comply/adhere with cGMP regulations, policies, SOPs and batch records

• Assist the Validation department with the operation and execution of engineering projects related to all phases of the lyophilization process.

• Under the supervision of the Sr. Manager Facilities and Lyophilization Supervisor, installs, maintains, operates repairs and troubleshoots low-temperature refrigeration systems.

• Installs, maintains, overhauls, and operates refrigeration equipment including compressors, pumps, evaporators, expansion valves, solenoid valves, all controls, condensers, and other related components.

• Focus on process improvement throughout the manufacturing and packaging areas.

• Coordinate and perform preventive/reactive maintenance on lyophilization equipment.

• Maintains detailed maintenance and spare parts records.

• Coordinates contracted maintenance activities with vendors.

• Assists in qualification of equipment/facilities as needed.

• Compiles, analyzes, draws conclusions, and provides written documentation related

to the maintenance and lifecycle of production systems.

• Administers project management controls and reports status to senior management.

• Involved in the oversight and coordination of activities that include design,

specification creation, procurement, construction management, repair of production

and facilities equipment.

• Utilizing the Building Automation Systems (BAS) monitors lyophilization systems,

manufacturing and laboratory environments, refrigeration units, incubators, etc.

• Operates BAS terminals to monitor, trouble shoot, and maintain applicable system

performance consistent with required unit and/or area conditions, following all

change control procedures.

• Ability to read PID drawings. Control schematics; ability to analyze refrigeration

problems and take corrective action; ability to upload and download programs and

utilize computer-based Building Automation Systems for trouble shooting and

monitoring system performance.

• Assignments are broad in nature, requiring originality and ingenuity, and rely on

collaboration, limited experience, and judgment to plan and accomplish goals

• Assists in programming, maintenance and troubleshooting of programmable logic

controllers and process/environmental monitoring systems.

• Establish procedures with some supervision.

• Performs equipment calibrations.

• The above statements are intended to describe the general nature of work performed by those in this job.