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Validation Engineer

Intellectt INC

Job Title: Validation Engineer

Location: Minneapolis, MN

Duration: 12 Months Contract

Job Summary:

We are looking for a Validation Engineer with 3 5 years of medical device industry experience to support equipment, process, and manufacturing validation activities.

Key Responsibilities:

  • Develop and execute IQ/OQ/PQ protocols.
  • Perform equipment and process validation.
  • Prepare validation protocols, reports, and documentation.
  • Investigate validation deviations and support CAPA.
  • Support risk assessments, change controls, and root cause analysis.
  • Ensure compliance with FDA, ISO 13485, and GMP requirements.
  • Work with Quality, Manufacturing, and Engineering teams.

Required Skills:

  • 3 5 years of Validation Engineering experience in medical devices.
  • Strong experience with IQ/OQ/PQ and process validation.
  • Knowledge of FDA 21 CFR Part 820 and ISO 13485.
  • Experience with deviations, CAPA, and change control.
  • Bachelor's degree in Engineering or related field.
Vacancy posted 2 days ago
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