Validation Engineer

at United Pharma Technologies Inc
Location Summit
Date Posted August 27, 2021
Category Engineering
Job Type Full Time


* Validation Engineer roles available at Multiple Locations in the United States

Typical Job Responsibilities:

  • Experience with developing, reviewing, and executing Validation lifecycle documentation (Commissioning & Qualification protocols, Validation Summary reports, Deviation Reports, Requirement traceability matrix, Periodic Reviews) in compliance with GAMP5 regulations and 21 CFR Part 11 enforced by US FDA for controlling manufacturing process and product quality in Pharmaceutical, biomedical and healthcare industries.
  • Experience with qualification of Equipment (Manufacturing/Process/Laboratory), Utilities, and facility.
  • Experience with temperature mapping of control temperature units using Kaye Validator and data loggers. Performing Pre- and Post- calibration of thermocouples.
  • Analyze and interpret validation test data using Statistical tools like Minitab to determine whether systems or processes have met validation criteria or identify root causes of deviations.
  • Software & Databases Knowledge: Kaye Validator Software, ValPro, Vaisala vertique Vlog, LIMS.

Skills Required:

  • Experience working in a cGMP environment.
  • Excellent technical writing ability.
  • Expert level experience with MS office.

Minimum Qualification Required:

  • Bachelor's degree in Pharmaceutical Sciences, Industrial Engineering, or a very closely related field of study

- provided by Dice