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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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
#J-18808-Ljbffr