Process Expert (m/f/d)
Core
Provide front-line technical and scientific expert support for process-specific issues to ensure on-time execution, compliance with cGMPs/SOPs, and continuous improvement in quality and productivity.
Role type
Process Expert (Manufacturing/Downstream Processing)
Builds
Downstream processes transferred from external/internal plants to the Kundl production facility
Domain
Biotechnology / Chemical Engineering / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Downstream processing concepts, Analytical skills, Data skills, Stakeholder management, GMP compliance, Production planning, Electronic batch file creation, Risk assessment
Preferred skills
Data Analytics
Technologies
Production IT systems, Electronic batch records (EBR), Manufacturing Execution Systems (MES)
Responsibilities
Act as Subject Matter Expert (SME) for product and process, Coordinate production operations to ensure on-time completion, Establish optimized order sequences within the Planning Time Fence, Define User requirement specifications for Manufacturing Systems, Design and create electronic batch files (EBR), Create MBR/BOM/Recipe in production IT systems, Participate in qualification and risk assessment processes
Seniority
Mid-level, hands-on IC