Calibration Technician

Department: Facilities and Engineering

Job Title: Calibration Technician

Reports To: Facilities and Engineer Manager

1. Role Purpose:

Under the supervision of the Facility and Engineering Manager, I/E Electronic & Instrumentation Technician 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 SOPs and cGMP regulations. The incumbent will execute daily work assignments and ensure timely completion of all scheduled and unscheduled events for instrumentation systems controls, and analytical laboratory instruments. 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 Control Laboratory Departments to help the company and all of its personnel to reach their goals in providing a safe, clean, and efficient environment.

2. Key Duties and Responsibilities:

• Follow cGMP policies, procedures, and training.
• Perform routine calibrations of instrumentation.
• Identify and correct measurement errors.
• Replace instrumentation and controls as needed.
• As necessary provide input and support for the design, installation, and upgrade of instrumentation and control systems.
• 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.
• Develop and/or revise calibration procedures and job plan while looking for ways to improve how calibrations and troubleshooting is performed in an attempt to make those practices more efficient.
• Maintain instruments, standards and tools. Perform equipment inspection prior to and upon return from vendor certification and review associated documentation.
• Assists supervision with the assigning, scheduling and prioritization of work order requests using maintenance management systems.
• Implementations of systems and procedures in Facilities and Engineering Department.
• Training and guidance to the personnel who are working in maintenance Department by oral and practical things to execute their Roles and responsibilities with safety and compliance.
• Preparation, review & Coordination in the Execution of IQ, OQ and PQ protocols of engineering & process related equipment.
• Preparation and review of Standard Operating Procedures related to Facilities & engineering department.
• Preparation and review of Calibration Work Instructions (CWI’s) and Standard Operating Procedures (SOP’s) related to Facilities & Engineering Department.
• Performing scheduled preventive maintenance, and field Instruments calibrations for all the Facilities & Engineering & process related equipment’s.
• Documentation of all Instruments calibration reports and equipment preventive maintenance & work orders.
• Working on the work order for the engineering & process related equipment’s and completing them in a timely manner.
• Completing the work order for projects and document when completed.
• Coordinating on sending or performing the Standard instruments Calibration from the outside vendors either In-house or sending it outside for calibration.
• Perform Instrumentational maintenance for all process related Equipment’s.
• Comply with FDA guidelines/Company Policies of Data Integrity
• Other duties as required or delegated from the Supervisor or the Department Heads.

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

Education Requirement:

• Bachelor’s of engineering/technology or Diploma from a vocational school or college preferred
• Specialization (If any):
  • Electronics & Instrumentation and Electrical field

Experience Requirement:

N/A

5. Technical competencies/Certifications/Licenses:

Technical competencies

• Able to work with other technicians
• Demonstrated ability to multi-task and prioritize many different projects and workload
• Ability to work independently
• Ability to communicate effectively, (written and verbally) with peers, management, contractors and vendors
• Must be highly self-motivated, and a self-starter
• Experience/aptitude, ability to troubleshoot and repair equipment
• Ability to work all days and shifts, including overtime (24 hours a day, 7 days a week operation, including holidays)
• Ability to acquire and sustain gown qualification of for clean room environments
• Automated control for equipment operation.
• GMP experience working in a Pharmaceutical Facility or equivalent experience in a regulated industry.
• Experience working within a Computerized Maintenance Management System or a Computerized Calibration Management System.
• Blueprint and electrical schematic reading.
• Calibration of Instruments.

6. Physical Demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception

b. Work environment:

N/A