Manufacturing Engineer
Core
Transferring and scaling up pharmaceutical/biopharmaceutical processes from Chemical Development to GMP manufacturing operations.
Role type
Manufacturing Engineer (Process Transfer & Scale-up)
Builds
GMP-compliant pharmaceutical/biopharmaceutical products
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process scale-up, Technical writing, GMP compliance, Change control management, Root cause analysis, SOP development
Preferred skills
Large-scale unit operations, GMP facility experience, Interdepartmental project coordination, Regulatory agency knowledge
Technologies
Automated equipment methods, Data capture forms, Batch record systems
Responsibilities
Transfer and scale-up new processes from Chemical Development into Manufacturing; Write and review process documentation and automated equipment methods; Generate change control records, risk assessments, and CAPA; Lead investigation of major process deviations; Coordinate revision of standard operating procedures (SOP)
Seniority
Mid-level, hands-on IC
