Laboratory Systems - IT Lab Support Analyst

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

Join Our OnSite Team in Bern Switzerland as a: Laboratory Systems IT Lab Support Analyst (m/w/d)

As a Laboratory 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 onsite 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 QCExcellence 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.
• Indepth understanding of the GAMP 5 framework and experience in creating qualification and validationrelated 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 crossfunctional teams and users to ensure endtoend 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 fulltime onsite at our Bern Switzerland office 08:00 AM 05:00 PM).

Our Benefits

We encourage you to make your wellbeing a priority. Its 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 highquality 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.

Do work that matters at CSL Behring!