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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