Bioprocess Engineer, Deviation Investigation 80%-100% (m/w/d)
Core
Lead GMP deviation investigations for manufacturing, cleaning, and qualification events to ensure quality and safety of biopharmaceutical therapies.
Role type
Senior Bioprocess Engineer (Deviation Investigation)
Builds
GMP-compliant biopharmaceutical products
Domain
Biopharmaceutical manufacturing / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP deviation investigation, root cause analysis, CAPA management, impact assessment, product quality assessment, stakeholder collaboration, technical data analysis, scientific documentation
Preferred skills
Experience with Module L processes, recurring issue analysis, continuous improvement initiatives
Technologies
GMP systems, investigation software
Responsibilities
Lead and author GMP deviation investigations for manufacturing, cleaning, qualification, and operational events; Conduct structured fact finding, event reconstruction, root cause analysis, impact assessments, and recurrence evaluations; Partner with cross-functional teams to define effective CAPAs; Drive deviation records through drafting, review, approval, and closure; Maintain inspection-ready investigation records; Support internal and regulatory inspections by presenting investigation outcomes; Contribute to deviation reduction and standardization of investigation practices
Seniority
Senior, hands-on IC
