Manufacturing Operator - Biologics

Job Description

Job Description

Job Title : Manufacturing Operator – Biologics

Location : Irvine, CA

Industry : Pharmaceutical Manufacturing

Employment Type : Contract

Position Overview :

Our client, a leading pharmaceutical company based in Irvine, CA, is seeking an experienced Manufacturing Operator with a strong background in BSL-3 (Biosafety Level 3) environments to support biologics production operations. This is a hands-on role responsible for executing critical manufacturing processes in a highly controlled environment, including stainless steel chromatography and biologics handling.

Key Responsibilities :

• Operate and monitor equipment on the biologics manufacturing line in accordance with GMP and safety protocols.
• Perform production activities involving stainless steel chromatography systems, filtration, and other downstream processing equipment.
• Work within a BSL-3 laboratory environment, ensuring all operations comply with stringent biosafety and containment protocols.
• Handle Grade C & D cleanroom activities, including aseptic techniques, material transfers, and environmental monitoring support.
• Adhere to all gowning and de-gowning procedures, maintaining strict compliance with BSL-3 and cleanroom standards.
• Participate in setup, operation, and cleaning of equipment and cleanrooms to ensure readiness for production activities.
• Assist with documentation of batch records, deviation reports, and standard operating procedures (SOPs).
• Collaborate with cross-functional teams including QA, Validation, and Engineering to ensure smooth production flow.
• Troubleshoot and report equipment and process issues promptly.

Qualifications :

Preferred Qualifications :