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Calibration Medtrology Tech - 54788703 - JL

Job Code: 54788703
Job Location: SANTA ANA, CA
Category: Technicians
Last Updated: 01/11/2017
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Job Description:
Provide calibration and metrology support for production areas, cleanrooms, and laboratories throughout manufacturing plant, supporting Manufacturing, Facilities, Microbiology, and R&D departments. Perform scheduled and unscheduled calibrations, complete and retain documentation, and maintain calibration standards as required per standard operating procedures. Provide calibration and technical support to other Calibration Technicians, Engineers, and Equipment Owners for system qualifications, investigations, and other items and as required.  
The technician will be expected to evaluate and improve calibration processes, complete change orders, conduct failure investigations using root cause analysis techniques, attend production meetings, and act as an authority throughout the facility on calibration requirements. Technician will also be expected to use calibration expertise to implement new equipment, methods, and techniques to the department to continuously improve the calibration competency at the facility.
Job functions are to be performed under limited supervision while meeting all applicable Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements. Calibrations and measurements are to be traceable to the International System of Units (SI) using appropriate reference standards and maintaining NIST traceability. Test and measurement equipment range from general-purpose physical and dimensional equipment to custom built sterilizers. Disciplines comprise: Mass, Temperature, Humidity, Vacuum, Length, Optics, Pressure, Dimensional Metrology, Force, and Flow.
POSITION RESPONSIBILITIES:
• Plan and coordinate scheduled calibrations with minimal impact to production processes. Includes interaction with all levels of production, maintenance and laboratory management as well as completion of calibration, documentation per GDP requirements, and adjustment of calibration mechanisms as necessary to obtain specified operational performance of device or instrument.  
• Perform unscheduled calibrations, troubleshooting, and minor repair on a variety of analytical equipment and instrumentation for manufacturing and laboratory use and adjust calibration mechanisms as necessary to obtain specified operational performance of device or instrument.  
• Entering and maintaining calibration results and documentation into hard copy files and/or calibration tracking/documentation computer system as required.  
• Maintain the Metrology/calibration recall program and associated documentation requirements in conformance with such standards as the ISO 17025, ANSI/NCSL Z540-1, GMP’s, etc.  
• Ensure equipment is properly labeled with current calibration information for the purpose of identification and calibration status.  
• Maintain calibration standards in lab and ensure adequate equipment is available, calibrated with all appropriate documentation, NIST traceable, and able to provide adequate TAR for intended uses.
• Provide technical expertise on equipment to support testing, qualifications, investigations, and other engineering work.
• Identify calibration vendors capable of performing required calibration services for standard calibrations/re-certifications and repair of instruments. Interact with vendors as required.
• Review instrument owner’s requisitions for repair, replacement, or purchase of new tooling/equipment used for inspection, testing, or measurement to ensure the Calibration Laboratory has the capability to calibrate and maintain the equipment.  
• Collaborate with instrument owners on equipment calibration specifications, including tolerances, calibration points, and calibration interval using metrology and calibration expertise.  
• Collaborate on, review, and approve in-house calibration procedures and new process standards. Perform critical analysis and facilitate improvement to procedures as required.  
• Work overtime when necessary to support high priority requests or meet project goals.  
• Comply with all GMP, cleanroom hygiene, and control of personal contaminants requirements for working in ISO cleanroom environments and per site procedures.  
• Act in accordance with site EHS and safety requirements, reporting incidents as required.  
• Plan, coordinate, and review the work of calibration service suppliers and perform calibration supplier audits as needed.  
• Evaluate calibration procedures to identify gaps or potential areas for improvement.
• Originate and process document change orders.
• Own and complete all aspects of NCMRs.
• Attend production and department meetings providing calibration support to ensure site goals can be met.
• Perform other duties as assigned.
 
Requirements:
BASIC QUALIFICATIONS:
• Full use and application of standard principals and techniques for calibration and metrology.
• Skill in using word processor, spreadsheet and other general office applications.
• Experience with troubleshooting and performing minor repairs on mechanical and electrical equipment.
• Strong critical thinking and problem solving skills.
• Technical writing competency.
• Effective communication and interpersonal skills and the ability to work cross functionally in a highly collaborative environment.
• Highly focused, detail oriented mindset in performing work and documentation.
• Strong organizational skills.
• Ability to multitask and manage competing priorities.
• Leadership qualities.
REQUIRED EDUCATION:
High School graduate plus two years trade school or college in technical field.
REQUIRED YEARS OF EXPERIENCE:
• 3+ years metrology experience.
• 6+ years technical experience.
REQUIRED KNOWLEDGE:
• Demonstrates knowledge of current technical methods and equipment.
• Demonstrates strong knowledge of calibration regulations, requirements, and principles.
• Experience with multi-meters, power supplies, oscilloscopes, timers, pressure/vacuum gages, Temp and RH gages, recorders, micrometers, calipers, pin/plug gages, etc.  
DESIRED/PREFERRED QUALIFICATIONS (optional):
• Calibration experience in temperature, humidity, pressure and torque.
• Calibration experience in electronic and mechanical systems.
• Calibration experience in PLC or PC platform applications.
• Experience working with electronics and electronics systems.
• Experience with calibration recall programs and softwares.
• AA Degree or higher in an Engineering discipline or equivalent training and certification from a vocational trade school.
• ASQ Calibration Technician certification.
• Understanding of Quality System requirements and concepts.
• Knowledge/experience working with FDA/ISO regulations and GMP/GDP requirements.
• Experience with calibration in manufacturing facility.
• Experience in medical device field.
 
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or techteam@entegee.com.
 
Please reference job # 54788703JL
 
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
 
 

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