SENIOR INSTRUMENTATION / CALIBRATION TECHNICIAN WITH GMP
DURHAM, NC
DURHAM, NC
Onsite.
The pay ranges between $48.30 - $49.37 per hour.
Project Description:
- 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, PAS-X, DeltaV, and BAS for PM data entry, report generation, and equipment data analysis.
- 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.
Required Skills:
- High School Diploma/GED or higher.
- 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.
- 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 (during off-hours) to include days, nights, and weekends on a rotational basis with other team members.
Preferred 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 another 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.
This 6+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Malika: malika@alphaconsulting.com
ALPHA'S REQUIREMENT # 23-01877
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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