Night Shift Calibration & Maintenance Technician

Role Summary

Night Shift Calibration & Maintenance Technician

Responsibilities

• Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns) | Support Equipment (e.g. washers, autoclaves, tube welders/sealers)
• Utility systems (e.g. Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, vapor compression stills, compressed gas systems)
• Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)
• Clean-In-Place (CIP) Systems
• Maintenance Equipment (e.g. tools and testing equipment)
• Work with and troubleshoot complex process systems to include bioreactors, filtration skids, chromatography columns, washers, autoclaves and CIP skids
• Routine calibrations including but not limited to Flow, Level, Temperature, Pressure, Humidity, Speed, and Process Analytical Instruments
• Installation, testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment
• Develop standard operating procedures (SOPs), engineering change request (ECRs), preventative maintenance (PM) plans/calibration procedures, task lists, etc., as required
• Order and maintain spare parts for assigned process equipment
• Interface with other departments, contractors and disciplines on scheduling calibration and maintenance of equipment/utility systems
• Assist with execution of maintenance, automation, validation and additional testing
• Responsible for written documentation of activities
• Work within a team to perform maintenance and troubleshooting activities. Completes preventative maintenance and calibration work orders, resolves deviations and evaluates equipment performance for efficient operation
• Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures
• Compliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines

Education

• High School Diploma/GED or higher

Experience and Skills

• Minimum of two years of plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical, advanced mechanical, HVAC, and/or multi-stage refrigeration systems)
• Proficiency in computer systems and applications: Microsoft Office (Word, Excel and Outlook) | Programmable Logic Controllers (PLCs) | CMMS Calibration/Maintenance Database Systems
• Principled and good verbal and written communications
• Effective time management
• Wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses, arc flash garments as needed, etc.
• Clean room gowning during performance of some job duties (clean room safety shoes, clean room shoe coverings, clean room garments, hair coverings, safety glasses)
• Effective maintenance, troubleshooting, and problem-solving
• Manage multiple priorities and advance several tasks in parallel
• Demonstrated mechanical aptitude
• Proficient in the use of general hand and power tools, instruments and testing apparatus commonly used in maintenance and instrumentation
• Ability to read P&ID's, electrical drawings, blueprints, etc.

Preferred

• Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
• Clean room or GMP/regulated manufacturing environment
• Installation, operation, maintenance and/or troubleshooting experience with automated process equipment in the biopharmaceutical field
• GMP compliant maintenance database systems
• Knowledge of SAP and Delta V
• Associate degree in Industrial Systems, Mechanical, Instrumentation, Electronics, or Electrical preferred

Additional Requirements

• Schedule: Routine shift will be 2-2-3, 12-hour night shift schedule, including holidays and alternating weekends; on-call nights/weekends; 8-hour weekday schedule until safety courses/qualifications are completed
• Physical: Able to lift 50 lbs., climb ladders and stairs, work on platforms and equipment above floor level