Validation Engineer

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.