Prozessingenieur Downstream Production (m/w/d), HBS
Core
Planning, execution, and monitoring of large-scale Downstream Processing (DSP) steps including filtration and chromatography under GMP conditions for biopharmaceuticals.
Role type
Senior Process Engineer (Downstream Production)
Builds
Biopharmaceutical drugs and vaccines at GMP scale
Domain
Biotechnology / Biopharmaceutical Manufacturing
Required skills
GMP production experience, chromatography, filtration technologies, virus inactivation, process transfer, process validation, PPQ, Manufacturing Science & Technology (MSAT), process robustness, control strategies, lifecycle considerations
Preferred skills
Late-stage clinical or commercial biopharmaceutical manufacturing experience, technology transfer, process optimization
Technologies
Chromatography systems, filtration equipment, GMP documentation systems
Responsibilities
Plan, execute, and monitor DSP steps (filtration, chromatography) at 250-1,000 liter scale; Create and update GMP-compliant documents (SOPs, Batch Record Reviews); Plan and coordinate process transfers from development to production; Optimize processes for yield and efficiency; Ensure compliance with GMP standards and support audits/inspections
Seniority
Mid-Senior, hands-on IC
