Bioprocess Engineer DSP
Core
Planning, execution, monitoring, and documentation of commercial and clinical manufacturing campaigns in Downstream Processing (DSP) to manufacture medicines.
Role type
Senior IC bioprocess engineer (downstream processing)
Builds
Biopharmaceutical medicines
Domain
Biopharmaceutical manufacturing / Downstream Processing
Required skills
Biopharmaceutical manufacturing expertise, Downstream Processing (DSP) knowledge, cGMP compliance, Risk management, Process troubleshooting, Project leadership, GMP documentation
Preferred skills
Capital project experience, Commissioning and qualification, Change control management, Audit representation
Technologies
cGMP systems, Manufacturing execution systems, Risk assessment tools
Responsibilities
Lead and oversee DSP manufacturing campaigns ensuring cGMP compliance; Act as manufacturing Functional Lead coordinating cross-functional teams; Drive risk management activities including SHE and operational risk assessments; Maintain GMP documentation such as SOPs and records; Train and support manufacturing personnel; Represent manufacturing in capital projects and technology transfers; Lead continuous improvement initiatives and serve as manufacturing representative during audits.
Seniority
Senior, hands-on IC
