Laboratory Execution Systems IT Specialist

vor 4 Wochen

Bern, Bern, Schweiz CSL Behring Vollzeit

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. We are seeking a skilled Laboratory Execution Systems IT Specialist to join our team in Bern, Switzerland.

The successful candidate will be responsible for maintaining and supporting the Quality Control (QC) computerized laboratory systems, ensuring they meet compliance and qualification standards in line with industry GxP best practices and regulations.

As a Laboratory Execution Systems IT Specialist, you will collaborate closely with department managers across Quality Control (QC), Digital Quality (DQ), and Quality Assurance (QA) functions to ensure the effective operation of QC lab systems.

The main responsibilities of this role include:

  • 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.
  • GxP Compliance & Quality Management: Oversee the qualification, GxP validation, and change management of QC lab systems, ensuring 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, managing daily activities and coordinating 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, preparing and managing 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, and assist with data retrieval and reporting.
  • Compliance & Maintenance: Set up, configure, and maintain QC lab systems, adhering to industry standards, and perform emergency maintenance and system reviews to ensure GxP system health.

Requirements:

  • University degree or equivalent vocational training in a relevant field, with 5+ years of experience in a regulated industry, including at least 3 years in a similar IT/CSV support role.
  • In-depth understanding of the GAMP 5 framework and experience in creating qualification and validation-related documentation.
  • Certifications (Beneficial): ITIL, Prince2, Microsoft MCSA, or Cisco CCNA.
  • Experience with QC laboratory applications such as OpenLab, Chromeleon, Empower, UVWinLab, Spectrum, LabX, and NuGenesis.
  • Familiarity with QMS systems like Veeva Vault and TrackWise.
  • Experience with service support tools such as ServiceNow and asset inventory management tools.
  • Thorough knowledge of Windows client operating systems (XP, 7, 10), server operating systems, Active Directory, storage and backup solutions, and network assets.
  • Knowledge of server, storage, and virtualization standards, techniques, and tools. Experience with Acronis and CommVault is a plus.
  • Proven experience in coordinating tasks and managing small groups effectively.
  • Proven ability to effectively collaborate with peers, cross-functional teams, and users to ensure end-to-end product and process quality.
  • Strong written and verbal communication skills in both German (level C1 CEFR) and English (level A2 CEFR) are essential.
  • Availability to work full-time on-site at our Bern, Switzerland office (08:00 AM – 05:00 PM).

Why work at CSL Behring?

We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.

About CSL Behring:

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us:

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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