Biotech Process Engineer
Core
Support complex research, process changes, and technology transfers to optimize biotech production processes within a highly regulated GMP environment.
Role type
Biotech Process Engineer
Builds
Biotech production processes and products
Domain
Pharmaceutical manufacturing / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Data analysis, Process improvement, Continuous Process Validation (CPV), Protocol development, Change control management, Technical reporting, Stakeholder collaboration
Preferred skills
Upstream Processing, Downstream Processing, GMP compliance, Study planning, Global network collaboration
Technologies
GMP guidelines, Process validation tools
Responsibilities
Develop and implement production process improvements based on data analysis; Execute and follow up on the Continuous Process Validation (CPV) program; Lead or support multidisciplinary improvement projects; Translate improvement proposals into study plans with planning and milestones; Interpret study results and process data to drive concrete actions; Prepare or review protocols, technical reports, and process documentation; Support new product introductions and technology transfers; Collaborate with global technical networks to implement best practices.
