Staftonic LLC
Overview
Role: Validation Engineer. Focus on validating medical equipment and systems to ensure they meet industry regulations and performance standards.
Responsibilities
- Develop and execute validation protocols (IQ/OQ/PQ) for medical equipment.
- Perform equipment calibration, testing, and troubleshooting.
- Ensure compliance with FDA, ISO, and other regulatory standards.
- Support risk assessments and process validations.
- Collaborate with cross-functional teams (QA, R&D, Manufacturing).
Requirements
- Bachelor’s in Engineering or related field.
- 5+ years of validation experience (medical equipment or devices).
- Hands-on experience with IQ/OQ/PQ, GMP, and GDP.
- Familiarity with FDA 21 CFR Part 820, ISO 13485.
- Strong technical and problem-solving skills.
Preferred
- Experience with software validation (e.g., LabVantage, LIMS).
- Knowledge of sterilization processes (e.g., autoclaves).
- Attention to detail and ability to work independently.
Seniority level
- Mid-Senior level
Employment type
- Contract
Location
San Diego Metropolitan Area
Compensation
$85,000.00-$120,000.00
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