Cell Processing Specialist

Major accountabilities:

• Ownership for the processing of the assigned Patient starting material in the clean room environment.
• Ability to gown aseptically and work in a clean room environment (A, B and C) areas for extended periods of time.
• Day 0, cell washing and Harvest processing with the ability to work with automated equipment such as the CS5 and Sepax
• Verification of intermediate process days which include expertise with the wave bioreactor, NC-200 and in process environmental monitoring
• Maintains and prepares equipment/environment for use
• Proficient in the use of production related IT systems such as SAP, LIMS and MES
• Documents all steps in the assigned Batch record in line with GMP requirements
• Conduct all necessary processing/verification steps for the assigned lot with highest skill level of aseptic technique.
• Conduct all necessary processing/verification steps for assigned lots of media with the highest skill level of aseptic technique
• Assist on Deviation Investigations and Inspections
• Participation in assigned qualification/ validation activities
• Responsible for Successful on time completion of required training curriculum comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
• Maintains an “audit ready” module
• Perform other duties as assigned; i.e. batch record review, process streamline improvements, safety walks

Languages :

• English.

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