The position of Senior Instrumentation/Calibration Technician is recognized as a knowledgeable resource in maintenance, calibration, and technical areas and consulted in decision making. The individual in this role will be accountable for maintaining equipment data, performing Preventative Maintenance (PM) and unplanned corrective repair maintenance, calibration execution, Maintenance/Calibration documentation, schedule adherence, customer interaction, equipment performance analysis, and writing maintenance/calibration work instructions. The Senior Instrumentation/Calibration Technician will use computerized systems such as SAP, ProCal, Client-X, DeltaV, and Client for PM data entry, report generation, and equipment data analysis.
Responsible for supporting:
Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns, single-use equipment, etc.)
Support Equipment (e.g. washers, autoclaves, tube welders/sealers)
Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)
Clean-In-Place (CIP) Systems
Maintenance Equipment (e.g. tools and calibration equipment)
Respond to calls off hours including weekends and nights when equipment in his/her area of responsibility fails
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.
Installation, testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment.
Efficient and safe calibration and repair of instrumentation including temperature, pressure, conductivity, humidity, multi- function, etc., using Energy Control Procedures
Develops 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 repairs and maintenance of clean utility systems
Assists with execution of automation, validation and additional testing, as required
Responsible for written documentation of activities
Works 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 Energy Control Procedures
Compliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines
Effective communication (both written and oral) with IPT and Scheduling personnel
Physical requirements Must be able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level, remain standing for extended periods of time, etc.
Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses, etc.
Position requires clean room gowning during performance of job duties
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.
Required to support an on-call schedule to include days, nights and weekends on a rotational basis with other team members
Quals--
Education Minimum Requirement:
High School Diploma/GED or higher
Required Experience and Skills:
Minimum of 2 years of production maintenance and/or calibrations experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems).
Experience working in a clean room or GMP/regulated manufacturing environment
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.
Candidates are willing to be vaccinated/blood tested for titer for products manufactured within the facility, if required.
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 Education/Skills:
Minimum 5 years of production maintenance and/or calibrations experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems).
Associate Degree in Industrial Systems, Mechanical, Electronics, Electrical, Instrumentation, or other technical field
Prior experience in both Calibration and Maintenance
Installation, operation, maintenance and troubleshooting experience with automated process equipment in the biopharmaceutical field
Experience with GMP compliant calibration and maintenance database systems.
Knowledge of SAP, Procal •
Last updated on Nov 27, 2023