Bioprocess Engineer DSP
Core
Planning, execution, monitoring, and documentation of commercial and clinical manufacturing campaigns in Downstream Processing (DSP) to ensure compliant, safe, and efficient medicine production.
Role type
Senior IC bioprocess engineer (downstream processing)
Builds
Commercial and clinical biopharmaceutical manufacturing campaigns
Domain
Biopharmaceutical manufacturing / Downstream Processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biopharmaceutical manufacturing expertise, Downstream Processing (DSP) knowledge, cGMP compliance, risk management, root cause analysis, project leadership, technical troubleshooting
Preferred skills
Capital project leadership, commissioning and qualification expertise, audit representation, continuous improvement initiatives
Technologies
cGMP systems, risk assessment tools, validation frameworks
Responsibilities
Lead and oversee DSP manufacturing campaigns ensuring cGMP compliance; Act as Functional Lead for assigned products coordinating cross-functional teams; Drive risk management activities including SHE, EM, and operational assessments; Maintain GMP documentation such as SOPs and manufacturing instructions; Train and support manufacturing personnel; Represent manufacturing in capital projects for facility design and equipment selection; Lead continuous improvement initiatives and serve as representative during customer audits
Seniority
Senior, hands-on IC
