We seek a skilled, self-motivated individual to join our Calibration team. This role involves planning and performing calibration tasks, scheduling repairs, coordinating vendors, and troubleshooting/repairing instrumentation in a cGMP manufacturing environment.
Responsibilities:
- Conduct scheduled and on-demand calibrations on instruments and systems promptly, ensuring compliance with SOPs, standards, guidelines, and policies.
- Troubleshoot and repair moderately complex instrumentation on cGMP manufacturing skids, utility systems, and analytical instruments with minimal supervision.
- Maintain a safe work environment by following safety guidelines and using PPE as required.
- Support inspection readiness and facility upkeep in assigned areas for clinical and commercial manufacturing.
- Complete calibration work orders and tasks in the electronic Calibration and Maintenance System (Blue Mountain RAM) promptly.
- Initiate and support investigations of calibration failures.
- Keep calibration records and equipment files organized and accurate.
- Manage equipment sent to vendors for calibration/repair and schedule repairs for analytical instruments, overseeing vendors and contractors.
- Assist in reviewing Calibration Procedures.
Requirements:
- Minimum 2 years of calibration experience in the pharmaceutical or biotech sector, adhering to cGMP standards.
- High school diploma or equivalent; associate degree or technical certification preferred.
- Proficient in calibration techniques for various instruments and systems.
- Strong understanding of cGMP safety guidelines.
- Effective written and oral communication skills.
- Strong problem-solving abilities for troubleshooting instruments.
- Experience with MS Office; familiarity with Blue Mountain RAM or similar CMMS preferred.
- Good time management and organizational skills.
- Ability to work independently with minimal supervision.
- Basic knowledge of electronics, mechanical systems, control systems, PLCs, and utilities.
- Ability to read and interpret engineering drawings and schematics.
- Capable of climbing ladders and stairs of various heights.
Willing to work off-hours as needed for equipment emergencies.