Manufacturing Operator - Biologics

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:

• 2-6 years of hands-on experience in pharmaceutical or biologics manufacturing.
• Proven experience working in BSL-3 environments is required.
• Strong understanding of Grade C & D cleanroom classifications, practices, and regulatory standards.
• Demonstrated expertise in gowning procedures and cleanroom behavior in high-containment environments.
• Familiarity with stainless steel chromatography systems and downstream biologics manufacturing equipment.
• Knowledge of GMP, SOPs, and FDA regulatory requirements.
• Strong attention to detail, organizational skills, and ability to work independently in a highly controlled setting.

Preferred Qualifications:

• Experience in large-scale biologics production or vaccine manufacturing.
• Prior training or certification in BSL-3 safety practices