Manufacturing Operator – Biologics

Precision Technology - Irvine, CA, United States

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

 

 



Posted On: Tuesday, July 8, 2025



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