Senior Manufacturing Systems Specialist

hace 2 meses


Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completo

Job Summary:

We are seeking a Senior Associate - Manufacturing Systems Engineer to provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. The ideal candidate will ensure that all maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards, and FDA standards.

Key Responsibilities:

  • Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems, and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards, and FDA standards.
  • Ensure the maintenance team training program, standard operating procedures, and equipment/system operational standards are consistent throughout the team.
  • Participate in the coordination of technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues, and process maintenance issues.

Requirements:

  • Master's degree or Bachelor's degree and 2 years of Engineering experience or Associate's degree and 6 years of Engineering experience or High school diploma/GED and 8 years of Engineering experience.
  • Leadership and teambuilding skills.
  • Verbal communication skills in English and Spanish.
  • Strong written communication/technical writing skills.
  • Organization, facilitation, dealing with, and managing change skills.
  • Comprehensive understanding of validation protocol requirements.
  • Technical (Equipment Specific) analytical problem-solving skills.
  • Project management & planning, scheduling, and computer literacy skills.


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