Process Validation / Automation Engineer

Process Validation / Automation Engineer / CGT / On-Site / San Diego, CA
Our client is growing biotechnology company in San Diego, CA who recently completed an expansion of their manufacturing site in order to support an upcoming Phase III trial.

The ideal candidate has strong experience developing and executing Process Performance Qualification (PPQ) protocols for automated Cell & Gene Therapy Manufacturing Equipment. Additional responsibilities may include Computer Systems Validation (CSV) and implementation of a Manufacturing Execution System (MES). Drug Product / Drug Substance / Fill-Finish experience required.

Contract Duration: 6 Months with the possibility of extension or conversion to a full-time employee

Required Skills & Experience

• Ability to Qualify / Validate Automated Manufacturing Processes for Cell & Gene Therapy products
• Experience preforming Computer System Validation and familiarity with Manufacturing Execution Systems
• Strong understand of Clinical Manufacturing Regulations

Desired Skills & Experience

• 7-15 years working in Process Development / Validation / Automation
• Ability to work independently
• Ability to manage multiple projects concurrently