About the job
Core
Preparing technology transfer materials, performing process and cleaning validations, conducting computer system validations, reviewing URS, and supervising local staff training for factory operations.
Role type
Technology Transfer Engineer (Biopharmaceutical Manufacturing)
Builds
Validated biopharmaceutical production facilities and processes
Domain
Biopharmaceuticals / Chemical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (factory operations & validation)
Required skills
Process Validation, Cleaning Validation, Computer System Validation, URS review, Qualification, Factory Operations Supervision, Contamination Control Strategy
Preferred skills
Plasma fractionation experience, Utility setup for new pharmaceutical plants, Technology transfer experience, English proficiency
Technologies
GMP, URS, Validation Protocols
Responsibilities
Prepare technology transfer documentation, Execute process and cleaning validation studies, Conduct computer system validation, Review and qualify URS documents, Supervise and train local factory staff
Seniority
Mid-level (3+ years experience)
