Metrology Lead

Role Summary

Metrology Lead. This role is primarily responsible for calibrating and coordinating the calibration of a diverse range of electrical and mechanical equipment while adhering to good manufacturing practices. The role may also perform and/or assist with the installation, maintenance, testing and repair of the equipment.

Responsibilities

• Manage vendors and calibrate instruments such as RO systems, clean steam generators, autoclaves, parts washer systems, lab equipment, and manufacturing equipment.
• Develop and maintain the Blue Mountain Regulatory Asset Manager (BMRAM) system.
• Maintain all calibration records and instrument tagging.
• Write/develop Standard Operating Procedures (SOPs), and/or protocols.
• Write initial deviations using the QMS system.
• Assist in change control documentation and deviation notifications.
• Serve as information resource for validation technicians, contractors and vendors.
• Perform scheduled, new and emergency calibrations activities with vendors on all critical process equipment and lab instrumentation ensuring compliance with SOPs and cGMPs.
• Troubleshoot instrument control loops like temperatures, pressure, flow controllers, etc.
• Follow all environmental, health, and safety requirements and protocols.
• Understand schematics, logic ladder diagrams, and P&IDs.
• Identify/coordinate inventory for spare parts used on critical instruments.
• Support operations during 1st shift and be available after hours as needed to support the business.
• Assist in equipment selection, specification and commissioning.
• Other duties as assigned.

Qualifications

• Bachelors degree in STEM or High School degree with equivalent years of experience.
• Minimum 6+ years related experience in the areas such as temperature, pressure, flow (liquid & gas), pH, conductivity, humidity, lab instrumentation controllers, depyrogenation oven, steam generators, steam boilers, air compressor, vacuum pumps, and lab instrumentation.
• Knowledge of pharmaceutical manufacturing process equipment and lab instrumentation.
• Basic knowledge on cleanroom classifications.
• Familiarity with FDA, cGMP, SOPs, ASNI/NCSL, EU and ISO standards.
• Good organizational skills.
• Experience utilizing quality management systems like Trackwise and BMRAM preferred.
• Excellent verbal, writing and interpersonal communication skills.
• Ability to gown and gain entry to manufacturing areas wearing PPE (safety glasses, gloves, gowns, etc.).
• Ability to be available after hours as needed to support the business.
• Ability to lift up to 25 lbs.

Skills

• Calibration and metrology coordination
• Vendor management
• QMS and SOP development
• Troubleshooting instrumentation and control systems
• Documentation and record-keeping
• Understanding of schematics and P&IDs

Education

• Bachelors degree in a STEM field or equivalent experience.

Additional Requirements

• Schedule: In-office Monday-Friday.