Technical Engineering Specialist

hace 4 semanas


Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completo
Job Title: Specialist Tech Engineering

Job Summary:

We are seeking a highly skilled and dedicated individual to join our team as a Specialist Tech Engineering. The successful candidate will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. They will ensure that all maintenance team operations and activities are maintained in compliance with current corporate policies, industry standards, regulatory standards, and FDA standards.

Key Responsibilities:
  • Provide technical engineering support on system/equipment optimization strategies, upgrades, replacements, and modifications.
  • Ensure maintenance team operations and activities are maintained in compliance with corporate policies, industry standards, regulatory standards, and FDA standards.
  • Coordinate 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.
  • Provide technical support for the maintenance team during FDA and other regulatory agency inspections.
  • Support the maintenance team when responding to high purity water systems and environmental monitoring alert/action notifications.
  • Support the investigation on all alert/action notifications.
  • Support the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations, and related areas to ensure a continued state of compliance.
  • Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements, and optimization programs.
  • Evaluate sanitization and maintenance procedures.
  • Propose changes to the Department Manager.
  • Propose modifications for process, utility, and clean room systems to the Plant Engineering Group.
Requirements:
  • Master's degree and 3 years of engineering experience or Bachelor's degree and 5 years of engineering experience.
  • Above-average skills in leadership and teambuilding, verbal communication, written communication/technical writing, organization, facilitation, dealing with, and managing change.


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