Process Engineer
Core
Ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products through hands-on technical support, process validation, and continuous improvement.
Role type
Senior IC process engineer (cell therapy manufacturing)
Builds
Cell therapy products for clinical and commercial use
Domain
Biopharmaceuticals / Cell Therapy / Manufacturing Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cell therapy unit operations, GMP batch record execution, deviation investigations, root cause analysis, CAPA implementation, statistical analysis, technical writing, change control management, raw material qualification, electronic batch record systems
Preferred skills
late-stage clinical manufacturing support, process validation, commercial readiness, scale-up engineering runs, comparability studies
Technologies
cGMP/ATMP regulatory frameworks, control charts, univariate/multivariate analysis, electronic batch record systems
Responsibilities
Provide on-the-floor technical support for critical manufacturing campaigns; lead deviation investigations and implement CAPAs; perform data trending and analysis to ensure process robustness; support technology transfers and process validation (PPQ); author batch records, SOPs, and regulatory CMC documentation; deliver operator training and drive continuous improvement initiatives.
Seniority
Senior, hands-on IC
