What are the responsibilities and job description for the Bioprocess Technician position at Enigma Search?
Our client, a leading CDMO is seeking a Bioprocess Specialist for cell and gene therapy manufacturing processes. 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. You will collaborate with Operations, MSAT, Quality, and Facilities teams to ensure consistent production outcomes.
Responsibilities
- 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
- Other duties as assigned by management
Qualifications
