Job Summary

Provides ongoing support for manufacturing and quality control instruments. Responsible for installing, maintaining, testing, repairing, and calibrating a diverse range of electrical and mechanical equipment while adhering to good manufacturing practices.

Area Of Responsibility

• Calibrate instruments such as, RO systems, WFI stills, clean steam generators, Autoclaves, CIP systems, lab equipment, and manufacturing equipment.
• Perform scheduled, new and emergency calibrations activities with vendors on all critical process equipment and lab instrumentation ensuring compliance with SOPs and cGMPs
• Maintain calibration records and instrument tagging
• Basic knowledge on cleanroom classifications, and HEPA and cleanroom certification
• Write Standard Operating Procedures (SOPs)
• Must be proficient in troubleshooting instrument control loops like temperatures, pressure, flow controllers etc...
• Follow all environmental, health, and safety requirements and protocols
• Proficient at reading and understanding schematics, logic ladder diagrams, and P&IDs
• Assist in change control documentation and deviation notifications
• Write initial deviations using the QMS system
• Perform new instrument and equipment introduction using the qualified CMMS
• Assist in troubleshooting instrumentation issues as needed
• Assist in performing maintenance on lab instrumentation and manufacturing equipment
• 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

• Other duties as assigned

Work Conditions:

• Office
• Lab
• Manufacturing area/clean room area
• Maintenance Shop
• Exposure to noise, hot and cold, outside elements, some radiation

Physical Requirements:

• Stand, sit, walk, stoop, climb, use hands and fingers to handle or feel, reach with hands and arms
• Close and distance vision, talk, hear
• Wears personal protection equipment - safety glasses, gloves, gowning
• Use of autoclave
• Operates computer/office machines
• Exposure to noise
• Lift up to 25 lbs.

Travel Estimate

Up to 0 %

Education and Job Qualification

• High school diploma or equivalent is required
• Associate degree in STEM preferred
• Journeyman Certified Electronic Technician certification from an accredited agency is preferred
• Certified Control Systems Technician Level 1 from an accredited agency is preferred

• Work under general supervision, utilizing some clearly described procedures and/or general technical knowledge
• Good organizational skills
• Ability to work independently and meet deadlines with minimal supervision
• Excellent verbal, writing and interpersonal communication skills

Experience

• Minimum 4+ years related experience preferred
• Experience in temperature, pressure, flow (liquid & gas), pH, conductivity, humidity, lab instrumentation controllers, depyrogenation oven, freeze dryer, steam generators, steam boilers, air compressor, vacuum pumps, and lab instrumentation
• Experience soldering, use of DMM, and oscilloscopes
• Knowledge of pharmaceutical-manufacturing/lab instrumentation environment
• Experience utilizing quality manage systems like Trackwise, EDMS, MasterControl, or equivalent
• Strong knowledge of Blue Mountain calibration software or equivalent
• Thorough understanding of metrology principles defined in ASNI/NCSL required
• Familiarity with FDA, cGMP, SOPs, ASNI/NCSL, EU and ISO standards
• Knowledge of pharmaceutical manufacturing process equipment and lab instrumentation