IT Specialist for Qualification and Validation in Pharmaceutical Production | IT-Spezialist (m/w/d) für Qualifizierung und Validierung in der Pharmaproduktion
Eckert & Ziegler Radiopharma GmbH
Job Summary
This role is central to ensuring IT compliance and system integrity within a high-tech radiopharmaceutical production environment. You will be responsible for the administration and monitoring of computer-aided systems, including user management, patch management, and cybersecurity. A significant portion of the day-to-day work involves the validation of computer systems and the qualification of production equipment (DQ, IQ, OQ, PQ) in accordance with strict GMP standards. You will act as a bridge between internal departments and external service providers, managing technical changes and conducting risk analyses like FMEA. This position is ideal for professionals who enjoy technical documentation and want to represent the company during official audits and inspections. The role is particularly attractive due to its stable, non-shift work environment, flexible working hours, and the opportunity to contribute to life-saving cancer diagnostics and therapies within an internationally active group.
Required Skills
Education
University degree in Engineering, Pharmaceutical Technology, Medical Technology, Biotechnology, or a comparable qualification.
Experience
- Several years of professional experience in a GMP-regulated environment
- Proven experience in equipment qualification or computer system validation (CSV)
- Experience in managing IT processes within production environments, including networks and data security
- Experience in coordinating internal departments and external service providers for IT projects
- Experience in handling technical changes and deviation management
Languages
Additional
- Must have the ability to work independently and conscientiously; position is based at a fixed site (no large open-plan offices); requires strong communication skills for audit representation.
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