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Equipment Specialist

Montgomery Village, MD
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

  • 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.



Montgomery Village, MD


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