Night Shift Calibration & Maintenance Technician

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant linked to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

The Maintenance/Instrument Technician is accountable for providing equipment troubleshooting and maintenance support for a new product project/manufacturing operation. Develops standard operating procedures (SOP's) and preventative maintenance (PM's) plans, as requested. Accountable for written documentation of activities. Accountable for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively promotes, participates and embraces a team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required. 

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 Requirement

• High School Diploma/GED or higher

Experience and Skills

Required

• 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 re