Biologe (m/w/d)
Core
Ensuring GMP-compliant use and maintenance of computerized systems in the lab and actively supporting the digitalization of lab processes.
Role type
CSV Specialist (Computerized Systems Validation)
Builds
GMP-compliant laboratory data systems and digital workflows
Domain
Biopharmaceuticals / Life Sciences / Quality Management
Required skills
GxP regulatory compliance, Computerized Systems Validation (CSV), Software Qualification, Risk Analysis, CAPA management, Change Control, Audit support, Documentation creation, Training delivery, IT infrastructure qualification
Preferred skills
Experience with Empower, Chromeleon, viewLinc, PharmSpec, Magellan, PLA, Disaster Recovery planning, Business Continuity concepts
Technologies
Empower, Chromeleon, viewLinc, PharmSpec, Magellan, PLA, GAMP5
Responsibilities
Maintain and develop GMP-relevant computerized systems including database-based lab applications and document management systems. Conduct software validations according to GAMP5 and create corresponding documentation. Process and evaluate deviations, CAPAs, change control processes, and risk analyses. Support internal IT regarding IT infrastructure qualification. Support development, implementation, and maintenance of disaster recovery and IT business continuity concepts. Support internal and external audits and regulatory inspections.
Seniority
Mid-level, hands-on specialist