Manufacturing Specialist
3 weeks ago
Role Summary
We are seeking a 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
- Prepares process equipment, including bioreactors, ancillary equipment, stainless steel tanks, pressure transmitters, flow meters, aggregate traps, harvest discards, transfer lines, hoses, and small parts.
- Cleans and sterilizes equipment using CIP and SIP procedures.
- Performs daily or routine process operations in the cell culture and purification of biotech and biological products, including inoculating and monitoring bioreactors, processing cTCF material to Continuous Cell Separation, operating Chromatography, MAEF, MAVF, and TFF skids, and processing MAEF material using closed thaw process, step elution chromatography, membrane absorber, and filter clearance technology.
- Operates 50L, 200L, and 1000L collection bag technology to ensure robust collection, mixing, and dilution of products.
- Performs PEGylation of JIVI in process material using TFF technology.
- Operates automated bagging systems, blast freezes product for storage, dispenses chemicals, and formulates solutions.
- Prepares acids and bases as necessary, performs aseptic operations, takes, analyzes, and submits samples as required throughout the process, monitors and controls operation with computer control systems, completes all routine check sheets, cleans equipment, and maintains clean and orderly production facilities.
- Performs in-depth troubleshooting and root cause analysis of Kovaltry, Kogenate, and Jivi equipment and process failures, contributes to continuous improvement opportunities, and performs 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, including control of gas supply to bioreactor, micro-sparger assembly, anti-foam emulsion system, continuous cells separation equipment preparation and process/controls, membrane absorption chromatography process, basic knowledge of protein chemistry and purification systems, membrane absorber technology, viral removal techniques, and tangential flow filtration technology is preferred and may be considered in lieu of some or all of the educational requirements.
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