Description

You will manage computer system validation projects, develop test protocols, execute qualifications, and ensure compliance with cGMP regulations in a fast-growing gene therapy company.

Requirements

• Bachelors degree in Engineering
• 5+ years of validation experience
• Strong written and oral communication skills
• Ability to apply complex system validation principles
• Experience with BMS, CMS, and automation upgrades

Responsibilities

• Develop moderately complex test protocols for installation, operational, and performance qualification activities
• Investigate and troubleshoot validation problems and protocol non-conformances
• Initiate and own validation related change controls and corrective/preventative actions
• Support implementation of validation programs and perform periodic reviews of validated systems
• Represent validation department at team meetings and assist cross-functional teams