Senior Process Engineer, Manufacturing Sciences & Technology, Cell Therapy
Core
Senior Process Engineer ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products.
Role type
Senior hands-on IC process engineer (cell therapy)
Builds
Clinical and commercial cell therapy products
Domain
Biopharmaceuticals / Cell Therapy
Required skills
Cell therapy unit operations, GMP batch record execution, deviation investigations, root cause analysis, CAPA implementation, process validation, technology transfer, statistical analysis, control charts, technical writing, data analysis, problem-solving
Preferred skills
Process development, commercialization activities, automation/digital manufacturing, raw material qualification, CMC regulatory contributions
Technologies
Electronic batch records, control charts, GMP systems
Responsibilities
Provide on-the-floor technical support for critical manufacturing campaigns, lead deviation investigations and CAPA implementation, perform data trending and analysis, support technology transfer and process validation, author SOPs and batch records, deliver operator training, support regulatory submissions and audits
Seniority
Senior, hands-on IC