Bioprocess Specialist 2 - CONTRACT

The Bioprocess Specialist II plays a critical role in the cell and gene therapy manufacturing processes at GeneFab. This position involves executing both upstream and downstream processes in a GMP-compliant cleanroom environment, with responsibility for troubleshooting, deviation management, training, and contributing to 5S and other improvement initiatives with the goal of ensuring on time delivery and right first-time execution of Manufacturing batches.

Requirements

• Technical proficiency in aseptic techniques working with manufacturing equipment/instruments in open and closed systems
• Organize, coordinate, and lead production activities and ensure execution of processes in production while strictly adhering to cGMP standards
• Accurately complete batch records, forms, and documentation in line with Good Documentation Practices (GDP).
• Work as part of a team to support the execution of daily GMP manufacturing activities.
• Train staff in processing methods, aseptic technique, and cGMP clean room operations.
• Review batch production records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices.
• Initiate and support the closure of Deviation Reports and CAPAs