Position Overview

Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! This role is responsible for executing and documenting qualification and validation activities for a range of manufacturing equipment, facility systems, and processes in a regulated environment.

Immediate opening in Los Angeles, CA. Contact: Email resumes to jgarcia@simplybiotech.com or call 858.683.8070. For more information, visit www.simplybiotech.com.

Required Qualifications

• Experience with centrifuge and filter press on a manufacturing scale (no bench scale)
• Experience working with Kneat software
• 3-4 years experience as a CQV Engineer in a biotech environment

Key Responsibilities

• Support IQ, OQ, and PQ activities for manufacturing vessels, filtration units, centrifuges, CIP systems, controlled environments, purified water systems, alcohol distribution loops, compressed gases, and product transfer lines.
• Verify proper installation against vendor documentation and engineering drawings.
• Record equipment location and configuration details.
• Perform operational checks to confirm functionality under normal conditions, document results, and address any variances.
• Confirm performance metrics meet specified requirements and support validation of key process parameters.
• Plan and execute studies to confirm processes produce consistent, compliant results.
• Perform risk analyses, establish process controls, and validate analytical methods used in quality testing.
• Create and review associated records and reports.
• Develop and implement protocols to verify that cleaning procedures prevent contamination and carryover between products.
• Maintain thorough records of methods, data, and conclusions.
• Perform qualification activities for critical building and utility systems to ensure they support manufacturing requirements.

Benefits & Perks

• Compensation: $50-$55/hr