Calibration Supervisor

Kamis Professional Staffing Baltimore , MD 21201

Posted 3 weeks ago

Must be able to respond to emergency/on-call requests when needed

    *
  • The individual will perform various duties as required to * support 24/7 Plant and Process operations in a cGMP environment.
  • Responsible for ensuring that all day-to-day calibration * activities are completed as scheduled.
  • Supervise/Manage the calibration technicians daily work * and tasks.
  • Perform planned and unplanned Calibration activities.
  • Work with and manage vendors.
  • Maintain records of calibrations, repairs, parts and * equipment.
  • Supports and maintains the departmental training program.
  • Reviews and interprets analytical and statistical data, * calibration issues and performance trends
  • Troubleshoot mechanical, equipment, procedural and process * problems as appropriate in support of calibration activities.
  • Develop and maintain Calibration Maintenance documents, * Standard Operating Procedures, schedules and reports.
  • Write Deviations, CAPAs, Change Controls and OOT.
  • Provide calibration technical support to Production, QA, * QC, Facilities and Validation.
  • Will assist in failure investigations (root cause) and help * provide corrective/preventive actions to Deviations and equipment * failures.
  • Must comply with all applicable rules and regulations of * company and the Pharmaceutical / Biotech industry. This includes FDA * regulations such as cGMP, GDP, EH&S regulations and company * regulations such as the employee handbook.

Requirements

    *
  • High School Diploma/GED plus at least one of the following * certifications is required; IAS CST, ASQ CCT or US Military * Calibration certification.
  • 5+ years supervisory experience
  • Prior cGMP experience.
  • Experience working in a clean room and clean manufacturing * environment is required.
  • Experience with GMP manufacturing systems and equipment * (e.g. critical utility systems, purified water systems, clean steam, * pharmaceutical gasses, classified HVAC systems) is required.
  • Experience with general utility systems, boilers, * electrical, HVAC and refrigeration systems.
  • Experience with Rockwell Automation-based control system is * preferred.
  • Experience with Siemens Building Management Systems is a * plus.
  • Must have the ability to multi-task and coordinate their * workload by priority.
  • Must have a customer service focus and be quality driven.
  • Prior experience in an environment that implemented and * maintained advanced Calibration techniques, such as preventive and * predictive maintenance programs, is a plus.
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Calibration Supervisor

Kamis Professional Staffing