CQV Engineer Small Molecules 80-100% (m/w/d)
Core
Qualification and validation of process engineering equipment and facilities for small molecule manufacturing, ensuring process optimization and engineering knowledge standards.
Role type
CQV Engineer (Process Equipment Qualification & Validation)
Builds
Process engineering equipment and facilities for GMP production
Domain
Life Sciences / Pharmaceutical Manufacturing / Process Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process engineering equipment qualification, facility validation, change management (TCR), periodic review of qualified units, GMP production readiness, technical documentation management, audit representation, engineering knowledge transfer
Preferred skills
COMOS (Plant Engineering Software), DMS, TrackWise, SAP, Microsoft Office, German (fluent), English
Technologies
COMOS, DMS, TrackWise, SAP, Microsoft Office
Responsibilities
Update plant qualification for existing equipment upon changes, coordinate technical change requests (TCR), conduct periodic reviews of qualified units, control and archive changes to process flow diagrams, present and defend qualification dossiers during audits and inspections, perform equipment qualification for new builds, expansions, or existing units prior to GMP production
Seniority
Mid-level, hands-on IC
