Job Description

The Lead Lab & Clean Utilities Technician is responsible for providing equipment troubleshooting and maintenance support for production facility/manufacturing operation. This individual will partner with QO lab Plant Engineering management as well as the respective lab managers to provide calibration, maintenance and repair services to the QO lab in Durham, NC. Develops standard operating procedures (SOP's) and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively supports, participates and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required. 

Responsible for supporting: 

• Process Equipment
• Support Equipment
• Utility Equipment 
• Automated Systems 
• Clean-In-Place (CIP) Systems 
• Maintenance Equipment

Must be flexible to perform all the following functions and other tasks, as needed: 

• Experience working in a clean room or GMP/regulated manufacturing environment
• Ability to work with and troubleshoot complex process systems
• 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.
• Uses the SAP, and ProCal work order system to review work requests, identify required stock and non-stock materials, ensure availability, writes incursions for upcoming work, performs work orders to completion, and maintain equipment histories.
• 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
• Lead execution of maintenance, automation, validation and additional testing, as required
• Responsible for written documentation of activities
• Lead an area 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
• Effective communication both written and oral
• Physical requirements – Must be able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level.
• Walking, bending, crawling, and stooping is required. 
• Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses, etc. 
• Effective maintenance, troubleshooting, and problem-solving skills required
• Ability to 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.
• Routine shift will be day. Required to support an on-call schedule on nights and weekends and extended times when equipment runs dictate. 

Education Minimum Requirement: 

• High School Diploma/GED or higher

Required Experience and Skills: 

• Minimum of 7 years of plant maintenance experience with in depth knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical systems).
• Working knowledge of regulatory requirements in accordance with GMP manufacturing operations.
• Willing and able to lift 50 pounds, climb ladders and stairs, work on platforms and equipment above floor level. Walking, bending, crawling and stooping are required. 
• Proficiency in computer systems and applications including but not limited to:  Microsoft Office (Word, Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration/Maintenance Database Systems.
• Must demonstrate strong leadership skills, and good oral and written communication skills.
• Strong planning, scheduling, and time management skills
• Available for “On-Call” work rotation (during off-hours) and weekend overtime, as needed.

Preferred Experience and Skills:

• Associate Degree in Industrial equipment Systems, Mechanical, Electronics, Electrical or Instrumentation
• Experience working in a clean room or GMP/regulated manufacturing environment
• Installation, operation, maintenance and/or troubleshooting experience with automated process equipment in the biopharmaceutical field
• Experience with GMP compliant calibration and/or maintenance database systems.
• Knowledge of SAP and Allen Bradley PLC’s, Siemens Apogee BAS.

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