Manufacturing Engineer
Core
Transferring and scaling up chemical processes from development to manufacturing operations, ensuring quality and compliance.
Role type
Manufacturing Engineer (Process Transfer & Scale-up)
Builds
Manufacturing processes and batch production
Domain
Chemical manufacturing / GMP facilities
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process transfer and scale-up, SOP authoring and revision, batch record creation, change control management, deviation investigation, root cause analysis, vendor and customer interface, troubleshooting process equipment
Preferred skills
GMP facility experience, technical operations background
Technologies
Automated equipment methods, data capture forms, CAPA systems
Responsibilities
Transfer and scale-up new processes from Chemical Development into Manufacturing, Write or review new process documentation including master batch records and automated equipment methods, Coordinate the revision of standard operating procedures (SOPs) to support process transfer, Generate and review batch summaries for all batches produced, Lead or participate in the investigation of major process deviations and provide technical assistance to Quality Assurance, Assist manufacturing with problem-solving and troubleshooting process or equipment issues
Seniority
Mid-level, hands-on IC
