Validation Engineer

Intellectt INC; Minneapolis (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Intellectt INC is seeking a Validation Engineer in Minneapolis, MN for a 12-month contract. The role focuses on validating equipment, processes, and manufacturing with IQ/OQ/PQ protocols and strong conformity to FDA and ISO standards.

The ideal candidate has 3-5 years of medical device validation experience, knowledge of 21 CFR Part 820, and a Bachelor’s degree in Engineering. Collaboration with Quality, Manufacturing, and Engineering teams is essential.

Qualifications

• 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.

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.

Skills

3-5 years experience

IQ/OQ/PQ

Process validation

FDA 21 CFR Part 820

CAPA/change control

Education

Bachelor's degree in Engineering

Job description

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.