Career Opportunities with Validation & Engineering Group
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Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Shift: 3rd shift and weekends – 1 weekend Day free. Candidate must be available to work any shift, based on business needs. Shift will be Tuesday to Saturday or Sunday to Thursday.
Purpose:
Provides preventive maintenance, calibration, programming, configuration and repair services to instruments, systems or equipment that measure and control different variables in industrial manufacturing processes and those used in laboratories for analysis during the different stages of product development, applying mathematical knowledge and concepts of physics, electronics and mechanics; following written policies and procedures and, in addition, complying with current good manufacturing practices. The incumbent ensures the accuracy with which the instruments used in manufacturing measure these variables so that the processes and analyzes are carried out in a safe, consistent, and uniform manner so that the final product has the required efficiency and complies with the specifications and laws that govern the industry.
Responsibilities:
- Responsible for repairing, inspecting, modifying, and calibrating the instrumentation equipment and performing preventive and/or corrective maintenance used for the manufacture of pharmaceutical products in accordance with the regulations applicable to our industry (CGMP, OSHA, etc.) maintaining a high degree of reliability in a safe and efficient way.
- Comply with the AbbVie Policies, with the plant procedures, and the regulations and requirements of Good Manufacturing Practices (cGMP) of the Federal Food and Drug Administration (FDA).
- Calibrate and certify instruments used for the processes of operation or manufacture of pharmaceutical products.
- Certify the proper functioning of the instrumentation used for the final approval and control of the process of operation or manufacture of pharmaceutical products.
- Carry out their tasks according to the regularity and frequency determined by the calibration system, following the procedures and methods approved for such purposes.
- Carry out the maintenance tasks (Preventive, Corrective) observing and complying with the safety rules and procedures that apply to each activity.
- Inform, correct, and suggest improvements to observed unsafe situations.
- Document these tasks as assigned, complying with the applicable procedures.
- Properly document the calibrations performed using the forms and documents approved in the calibration procedures and/or Metrology Corporation.
- These include Calibration Work Orders, Out of Tolerance Reports, Repetitive Out-of-Tolerance Reports, etc., following the cGMP policies, procedures, and rules. Carry out corrective repairs on electrical and/or pneumatic instrumentation equipment.
- Perform inspections, problem analysis and take corrective actions to avoid recurrence.
- Provide technical assistance during the definition and documentation of methods and sequences of operations necessary to calibrate new equipment for primary measurement, testing, and in new systems of process control.
- Analyze the calibration data to determine trends and correction factors in Standards.
- Attend and complete the required internal training on environmental, health, and occupational safety in addition to local training and good manufacturing practices (cGMP).
- Use the required protective equipment (disposable respirator or PAPR) and notify the supervisor of incidents or unsafe conditions in the work area.
- Provide technical support and perform work during emergency situations in and outside of working hours, on holidays, during weekends or when the supervisor deems necessary.
Qualifications:
- Associate Degree in Technology of Industrial Instrumentation, Electronics or Electronic Engineering Technology.
- Minimum three (3) years of experience in the calibration, repair and programming of electronic or electro-pneumatic systems, analytical, and laboratory instrumentation at the industrial level.