** 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 technician’s 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.
- 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.