Instrumentation Calibration Specialist

2 months ago

Langhorne, Pennsylvania, United States Penn Life Sciences Full time
Job Overview

Department: Facilities and Engineering

Position: Instrumentation Calibration Specialist

Reports To: Facilities and Engineering Manager

1. Purpose of the Role:

In this role, the Instrumentation Calibration Specialist will work under the guidance of the Facilities and Engineering Manager. The individual will leverage their expertise in precision measurement science (Metrology), mathematics, physics, and electronics to assess, calibrate, troubleshoot, maintain, and repair various instrumentation and control systems. Adherence to established company policies, departmental protocols, and safety regulations is essential. The specialist will execute daily tasks and ensure the timely completion of both scheduled and unscheduled calibration activities for instrumentation systems and analytical laboratory instruments. This position will collaborate closely with Facilities, Engineering, Validation, Manufacturing, and Quality Control Laboratory Departments to support the organization in maintaining a safe, clean, and efficient operational environment.

2. Key Responsibilities:

  • Adhere to cGMP guidelines and training protocols.
  • Conduct routine calibrations of various instruments.
  • Detect and rectify measurement discrepancies.
  • Replace instruments and controls as necessary.
  • Provide input and support for the design, installation, and enhancement of instrumentation and control systems.
  • Identify and address "Out of Tolerance" conditions, implementing corrective measures to restore devices to specifications.
  • Engage in investigations and document the potential impact of any "Out of Tolerance" conditions on instrumentation and processes.
  • Develop and refine calibration procedures and job plans, seeking efficiencies in calibration and troubleshooting practices.
  • Maintain instruments, standards, and tools, performing inspections before and after vendor certification and reviewing related documentation.
  • Assist management in assigning, scheduling, and prioritizing work order requests using maintenance management systems.
  • Implement systems and procedures within the Facilities and Engineering Department.
  • Provide training and guidance to maintenance personnel to ensure safety and compliance in their roles.
  • Prepare, review, and coordinate the execution of IQ, OQ, and PQ protocols for engineering and process-related equipment.
  • Review and prepare Standard Operating Procedures pertinent to the Facilities and Engineering Department.
  • Draft and review Calibration Work Instructions (CWIs) and Standard Operating Procedures (SOPs) relevant to the Facilities and Engineering Department.
  • Perform scheduled preventive maintenance and field instrument calibrations for all Facilities and Engineering and process-related equipment.
  • Document all calibration reports and preventive maintenance work orders.
  • Complete work orders for engineering and process-related equipment in a timely manner.
  • Coordinate the calibration of standard instruments with external vendors, whether in-house or outsourced.
  • Conduct maintenance on all process-related equipment.
  • Ensure compliance with FDA guidelines and company policies regarding data integrity.
  • Perform other duties as assigned by supervisors or department heads.

3. Supervisory Responsibilities:

N/A

4. Education & Experience:

Educational Background:

  • Bachelor's degree in engineering/technology or a diploma from a vocational school or college is preferred.
  • Specialization:
    • Electronics & Instrumentation and Electrical fields.

Experience:

N/A

5. Technical Skills/Certifications:

Technical Skills:

  • Ability to collaborate effectively with other technicians.
  • Proven capability to manage multiple projects and prioritize workloads.
  • Ability to work independently and communicate effectively, both verbally and in writing, with peers, management, contractors, and vendors.
  • Highly self-motivated and proactive.
  • Experience in troubleshooting and repairing equipment.
  • Willingness to work all shifts, including overtime, as required.
  • Ability to achieve and maintain gown qualification for cleanroom environments.
  • Familiarity with automated control systems for equipment operation.
  • Experience in a pharmaceutical facility or a regulated industry.
  • Experience with Computerized Maintenance Management Systems or Computerized Calibration Management Systems.
  • Ability to read blueprints and electrical schematics.
  • Proficient in instrument calibration.

6. Physical Demands and Work Environment:

a. Physical Demands:

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

b. Work Environment:

N/A

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