CSV Engineer

A specialized Medical Device client in Ohio is in immediate need of a Computer System Validation Engineer for a 4-6 month project. This project must be completed onsite in the greater Cincinnati, OH area. There is a strong likelihood of extension based on performance.

• Responsibilities:
  Lead and execute Computer System Validations (CSV) in a regulated environment
• Perform equipment characterization and test method validations
• Develop and execute IQ/OQ protocols and author validation reports
• Conduct Installation Qualifications, Operational Qualifications, and Gage R&Rs
• Evaluate manufacturing and laboratory equipment to ensure compliance with quality and regulatory standards
• Write, execute, and close validation protocols with clear documentation and traceability

Requirements:

• BS Degree minimum; 5-10 years of relevant industry experience
• Hands-on experience with CSV in medical device or regulated GMP environments
• Strong background in equipment validation, IQ/OQ execution, and test method validation
• Experience performing equipment characterization and statistical analysis (e.g., Gage R&R)
• Proven ability to independently author and execute validation protocols and reports
• Working knowledge of quality systems and regulatory requirements