Manufacturing Technician

7 days 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 preparing process equipment, cleaning and sterilizing equipment, and performing daily or routine process operations in the cell culture and purification of biotech and biological products.

Key Responsibilities
  • Prepare process equipment, including bioreactors, ancillary equipment, and stainless steel tanks.
  • Clean and sterilize equipment using CIP and SIP procedures.
  • Perform daily or routine process operations, including inoculating and monitoring bioreactors, processing cTCF material, and operating chromatography, MAEF, MAVF, and TFF skids.
  • Process MAEF material using closed thaw process, step elution chromatography, membrane absorber, and filter clearance technology.
  • Operate 50L, 200L, and 1000L collection bag technology to ensure robust collection, mixing, and dilution of products.
  • Perform PEGylation of JIVI in process material using TFF technology.
  • Operate automated bagging systems and blast freeze product for storage.
  • Dispense chemicals and formulate solutions, prepare acids and bases as necessary, and perform aseptic operations.
  • Take, analyze, and submit samples as required throughout the process.
  • Monitor and control operation with computer control systems and complete all routine check sheets.
  • Clean equipment and maintain clean and orderly production facilities.
  • Perform in-depth troubleshooting and root cause analysis of Kovaltry, Kogenate, and Jivi equipment and process failures.
  • Contribute to continuous improvement opportunities and perform all operations in compliance with cGMP.
Requirements
  • Requires completion of two-years' college science courses in biology, chemistry, biochemistry, or microbiology, or a certificate from an accredited bio-technology academy.
  • Relevant bio-tech industry experience in cell culture bioreactor system assembly and use, continuous cells separation equipment preparation and process/controls, membrane absorption chromatography process, and basic knowledge of protein chemistry and purification systems is preferred.
  • Familiarity with cGMP's and applicable agency regulations is required.


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