Laboratory Execution Systems Specialist
Vor 6 Tagen
We are seeking an experienced IT professional to join our team as a Laboratory Execution Systems Specialist in Bern, Switzerland.
Job SummaryThis role involves maintaining and supporting Quality Control (QC) computerized laboratory systems to ensure compliance with industry GxP best practices and regulations. You will work closely with department managers across Quality Control (QC), Digital Quality (DQ), and Quality Assurance (QA) functions to ensure effective operation of QC lab systems.
Main Responsibilities- Technical Support & Troubleshooting: Analyze and resolve hardware, software, and network issues specific to QC lab systems, ensuring minimal downtime and system performance.
- System Administration & Configuration: Configure, implement, and administer servers and applications used in QC labs, including VMWare and Citrix, to maintain a stable and responsive environment. Manage data backups and handle software updates.
- GxP Compliance & Quality Management: Oversee the qualification, GxP validation, and change management of QC lab systems. Ensure compliance with industry standards and regulatory requirements.
- Local Team Coordination: Act as the local coordinator for a small team of IT GxP specialists and project resources in Bern. Manage daily activities and coordinate closely with the Europe Lead for support and guidance.
- Collaboration & Process Improvement: Partner with QC Business Process Owners and Quality Assurance to facilitate system changes, conduct risk assessments, and implement enhancements and process improvements.
- Custom Solutions & Documentation: Develop and maintain customized scripts and configuration utilities for QC lab systems. Prepare and manage documentation related to system validation, SOPs, and compliance.
- Server & Data Management: Oversee validated servers and GxP Data Servers in QC labs, ensuring data integrity and availability. Assist with data retrieval and reporting.
- Compliance & Maintenance: Set up, configure, and maintain QC lab systems, adhering to industry standards. Perform emergency maintenance and system reviews to ensure GxP system health.
The ideal candidate will have 5+ years of experience in a regulated industry, including at least 3 years in a similar IT/CSV support role. They will also have an in-depth understanding of the GAMP 5 framework and experience in creating qualification and validation-related documentation. A university degree or equivalent vocational training in a relevant field is required.
About CSL BehringCSL Behring is a global biotherapeutics leader driven by its promise to save lives. We develop and deliver high-quality medicines that treat people with rare and serious diseases.
Estimated Salary: $85,000 - $110,000 per yearBenefitsWe offer a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan, and paid time off.
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