IT- Systemadministrator (w/m/d) GMP / Computer System Validation
Core
Administration, operation, and monitoring of IT systems in a GMP-regulated environment, including server, network, virtual environment, and database management, as well as support for GMP-relevant applications like LIMS, DMS, QMS, and ERP.
Role type
IT System Administrator (GMP/CSV)
Builds
IT infrastructure and validated applications for a biomedicine company developing phage therapy solutions.
Domain
Biomedicine / GMP / Computer System Validation
Required skills
IT system administration, server management, virtual environments, network management, database management, role and permission management, IT security, Computer System Validation (CSV), data integrity (ALCOA+), regulatory compliance (EU-GMP Annex 11, FDA 21 CFR Part 11), documentation creation and review.
Preferred skills
Experience in GMP-regulated or validated environments, experience with Change Control and Re-Validation processes.
Technologies
LIMS, DMS, QMS, ERP, virtual environments, databases.
Responsibilities
Administration, operation, and monitoring of IT systems in a GMP-regulated environment; ensuring backup, restore, and archiving concepts according to regulatory requirements; managing user, role, and permission administration for GMP-relevant systems; participating in the implementation and further development of complex systems in a regulated environment; participating in Computer System Validation (CSV) according to EU-GMP Annex 11 and FDA 21 CFR Part 11; creating, maintaining, and reviewing validation documents such as URS, risk analyses, IQ/OQ/PQ, test scripts, and traceability matrices; contributing to Change Control, Re-Validations, and data integrity requirements; supporting Audit-Trail, logging, timestamp, and archiving concepts; collaborating with Quality Assurance, Quality Control, Production, and external IT service providers; supporting audits and inspections.
Seniority
Mid-level, hands-on IC