This position is responsible for ensuring calibration compliance of all necessary equipment and instruments through understanding of guiding SOPS, instrument OEM manuals, and end user requirements. Supports manufacturing operations (sterile/non-sterile) by ensuring equipment/instrument calibrations are performed at point of use (aseptically as required) when the equipment is available and in a timely manner. Day to day responsibilities will include completing assigned calibration tasks, including paperwork, and troubleshooting basic equipment, implementing fixes as necessary.
- Performs maintenance, testing, and calibration on a variety of circuits, components, analytical equipment and instrumentation for pharmaceutical laboratory and manufacturing equipment.
- Assists in planning calibrations and subtasks, limited planning required outside immediate assigned tasks.
- Assures that monthly calibration requirements are completed compliantly on time, extended, or equipment is tagged out of service if failing or overdue for calibration.
- Prepares calibration reports
- Specifies and requests purchase of components
- Disassembles and reassembles instruments and equipment, using hand tools, and inspects instruments and equipment for defects.
- Communicates and coordinates manufacturing equipment maintenance efforts with Engineering group and others as necessary.
- Manages the use of external contractors.
- Assures that all pertinent SOPs are being followed, maintains compliance with cGMPs.
- Proven ability to work under close supervision to complete assigned tasks and in a compliant manner
- High School degree required and Bachelor’s Degree (BA or BS) preferred.
- 0-3 years of relevant Metrology experience required. Previous experience in the pharmaceutical industry preferred.