Manufacturing Operator - Biologics
Precision TechnologyIrvine, CA, USjob_description.job_card.variable_days_ago
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job_description.job_card.job_description2-6 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. Experience in large-scale biologics production or vaccine manufacturing. Prior training or certification in BSL-3 safety practices
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 :
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Manufacturing Operator • Irvine, CA, US