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