Job Details

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.