IT Lab Support Analyst, Laboratory Execution Systems (m/w/d)

CSL Behring is a global biotherapeutics leader driven by its promise to save lives.

Join Our On-Site Team in Bern, Switzerland as a

As a Laboratory Execution Systems IT Lab Support Analyst, you will be responsible for maintaining and supporting the Quality Control (QC) computerized laboratory systems. Your role will focus on ensuring these systems meet compliance and qualification standards in line with industry GxP best practices and regulations.

In addition to your responsibilities as an IT Lab Support Analyst, you will serve as the local coordinator for a small team of IT GxP specialists and project resources on-site in Bern, overseeing daily activities with support and guidance from the Europe Lead.

In this position, 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. You will also work with internal teams, such as QC-Excellence Instruments and IT, as well as external Lab System Vendors.

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.

Who you are:

Your decisions will impact the validation status of GxP computerized laboratory systems. Therefore, your actions must be guided by a thorough understanding of existing SOPs, regulatory documents, the GAMP 5 framework, and alignment with local and global business needs and goals.

The following competencies are essential to your success:

• 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).