Lead Medical Device Validation Engineer (IQ/OQ/PQ CSV)

The Sentio Group; Minneapolis (MN); On-site; USD 151,536 - 192,864; Full time

Job summary

The Sentio Group in Minneapolis, MN is seeking a Validation Engineer to help expand US manufacturing capacity in a leading Class III medical device company. This role involves owning equipment, process, and computer system validation in a regulated cleanroom environment.

With a focus on writing protocols and executing validation tasks, you will collaborate with Quality and Manufacturing Engineering teams, ensuring compliance with ISO 13485 and 21 CFR 820. The position offers a competitive hourly rate of $110 - $140.

Qualifications

• 6+ years of validation engineering in medical devices or pharmaceuticals.
• Hands-on experience with IQ, OQ, PQ protocols.
• Comfortable working in cleanroom environments.

Responsibilities

• Author and execute IQ / OQ / PQ protocols.
• Lead computer system validation activities.
• Prepare validation documentation for audits.

Skills

Validation engineering expertise

Technical writing skills

Risk-based validation knowledge

Education

Degree in Mechanical, Biomedical, Chemical or Manufacturing Engineering

Tools

ISO 13485

21 CFR 820

GAMP 5

Job description

The Sentio Group in Minneapolis, MN is seeking a Validation Engineer to help expand US manufacturing capacity in a leading Class III medical device company. This role involves owning equipment, process, and computer system validation in a regulated cleanroom environment.

With a focus on writing protocols and executing validation tasks, you will collaborate with Quality and Manufacturing Engineering teams, ensuring compliance with ISO 13485 and 21 CFR 820. The position offers a competitive hourly rate of $110 - $140.