Sr. Tech, Operations

Job Description

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

The Senior Instrumentation Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibility project/manufacturing support. 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. 

Under the supervision of the Maintenance Manager and/or Lead, the selected candidate will utilize strong knowledge of precision measurement science (Metrology), mathematics, physics, and electronics to test, calibrate, troubleshoot, maintain and repair instrumentation/controls.  All duties must be performed in compliance with established company, department, and safety policies and procedures within GXP-regulated and non-GXP facilities. 

The incumbent will execute daily work assignments and ensure timely completion of all scheduled and unscheduled events for instrumentation systems controls.  The individual in this role will collect, compile, measure, summarize, and record data obtained during scheduled calibration and/or unscheduled work requests.  This position will work in conjunction with Facilities, Engineering, Validation, Manufacturing, and Quality Departments to help the company and all of its personnel to reach their goals in providing a safe, clean, and efficient environment.

Shift: 12-hour, 2-2-3 Day Shift

Responsible for supporting: 

• Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns) 

• Support Equipment (e.g. washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation) 

• Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics, Building Automation System (BAS)) 

• Clean-In-Place (CIP) Systems 

• Maintenance Equipment (e.g. tools and calibration equipment) 

• Support to Digital Platforms (e.g. SAP, ProCal, Brady)

• Initiate and complete routine calibration tasks, work with and troubleshoot complex process systems

• Contributes to the performance and results of the department

• Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units

• Decisions are guided by policies, procedures, and business plan; receives guidance from manager

• Knowledge of instrumentation, PLCs and electronic and pneumatic loop control systems

• Perform routine calibrations of instrumentation.

• Perform maintenance, troubleshooting, repair, design, installation, and configuration of equipment, instrumentation and control systems

• Perform out of tolerance reports

• Maintains calibration standards

• Identify “Out of Tolerance” conditions and perform corrective actions to return the device to within specification.

• Participate with investigating and documenting the potential impact that the “Out of Tolerance” condition may have had on the instrumentation and process.

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

• Ability to work with and troubleshoot complex process systems to include bioreactors, filtration skids, chromatography columns, washers, autoclaves, and CIP skids.

• Testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment.

• Support updates to preventative maintenance (PM) plans/calibration procedures, task lists, etc., as required.

• Assists with execution of automation, validation, and additional testing, as required

• Responsible for written documentation of activities

• Completes preventative maintenance and calibration work orders

• 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 maintenance, troubleshooting, and problem-solving skills required

• Ability to manage multiple priorities and advance several tasks in parallel

• Demonstrated instrumentation aptitude

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