Manufacturing Process Expert – Drug Product 80-100% (f/m/d)
Core
Subject Matter Expert providing front-line technical and procedural support for Drug Product manufacturing operations, ensuring cGMP compliance and driving process improvements.
Role type
Manufacturing Process Expert (Drug Product)
Builds
Sterile drug product batches
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Sterile manufacturing operations, cGMP guidelines, batch execution, troubleshooting, process optimization, CAPA management, electronic batch records, deviation investigations
Preferred skills
QA experience, compounding, filtration, steam sterilization, single use systems
Technologies
Trackwise, SAP, MES
Responsibilities
Execute manufacturing activities according to cGMP guidelines, provide technical support to shopfloor, secure batch safety and compliance, prepare and review electronic batch records, drive optimization projects, own process investigations and critical deviations, drive process changes and CAPAs, perform training activities
Seniority
Mid-level, hands-on IC
