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Validation Engineer

1 month ago

Davie, Florida, United States Aequor Technologies Full time
Job Summary

Under general supervision, this role reviews specifications and determines the critical aspects of facilities, utilities, computer systems, and manufacturing equipment with regard to product and process quality. The incumbent writes qualification protocols for operating systems and records related test results, prepares final reports that identify the results of protocol testing and the conditions of release, and ensures that all test data is gathered and recorded in accordance with cGMP requirements.

Key Responsibilities
  • Reviews electrical, mechanical, and software/computer specifications in manufacturer and blueprint form, and identifies critical parameters.
  • Writes protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.
  • Ensures that protocols are approved through proper channels and writes and revises validation protocols.
  • Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
  • Analyzes data to ascertain if it meets related protocol acceptance criteria and writes deviation reports as required upon failures to meet protocol acceptance criteria.
  • Writes final reports and assures that they are approved through proper channels.
  • Develops and communicates project timelines and status.
  • Complies with all GMP and safety requirements, SOPs, and Company policies and procedures.
Requirements
  • Bachelor's degree in Engineering or a related field from an accredited college or university.
  • Zero (0) to one (1) year of engineering validation experience, preferably in a pharmaceutical environment, or an equivalent combination of training and experience.