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Manufacturing Specialist

2 months ago

Berkeley, California, United States Randstad Life Sciences US Full time
Job Summary

We are seeking a highly skilled Manufacturing Technician to join our team at Randstad Life Sciences US. As a key member of our production team, you will be responsible for ensuring the efficient and effective operation of our biotechnology and pharmaceutical production processes.

Key Responsibilities
  • Equipment Preparation and Maintenance
    • Prepare process equipment, including bioreactors, stainless steel tanks, and ancillary equipment, for use in production processes.
    • Clean and sterilize equipment using CIP and SIP procedures.
  • Process Operations
    • Operate equipment for cell culture and purification of biotech and biological products, including bioreactors, chromatography systems, and membrane absorbers.
    • Monitor and control process operations using computer control systems.
  • Quality Control and Assurance
    • Perform quality control checks on products and equipment to ensure compliance with cGMP regulations.
    • Take and analyze samples as required throughout the process.
  • Troubleshooting and Root Cause Analysis
    • Identify and troubleshoot equipment and process failures, and perform root cause analysis to prevent future occurrences.
  • Continuous Improvement
    • Contribute to continuous improvement opportunities to enhance process efficiency and product quality.
Requirements
  • Education
    • Completion of two years' college science courses in biology, chemistry, biochemistry, or microbiology, or a certificate from an accredited bio-technology academy.
  • Experience
    • Relevant bio-tech industry experience in cell culture, bioreactor systems, chromatography, and membrane absorbers.
  • Skills
    • Basic knowledge of protein chemistry and purification systems.
    • Familiarity with cGMP regulations and applicable agency regulations.