Laboratory Systems Support Specialist
vor 1 Monat
CSL Behring is a global leader in the development and delivery of high-quality medicines that treat people with rare and serious diseases.
We are seeking an experienced Laboratory Systems Support Specialist to join our team in Bern, Switzerland.
Job SummaryThis role involves providing technical support and maintenance for our Quality Control (QC) computerized laboratory systems. The successful candidate will be responsible for ensuring these systems meet compliance and qualification standards in line with industry GxP best practices and regulations.
Responsibilities- Technical Support & Troubleshooting: Analyze and resolve hardware, software, and network issues specific to QC lab systems, minimizing downtime and ensuring 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, ensuring compliance with industry standards and regulatory requirements.
- 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.
To be successful in this role, you will need:
- A 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.
- An in-depth understanding of the GAMP 5 framework and experience in creating qualification and validation-related documentation.
- Certifications such as ITIL, Prince2, Microsoft MCSA, or Cisco CCNA are beneficial.
- Experience with QC laboratory applications such as OpenLab, Chromeleon, Empower, UVWinLab, Spectrum, LabX, and NuGenesis.
- Familiarity with QMS systems like Veeva Vault and TrackWise.
- Proven experience in coordinating tasks and managing small groups effectively.
- Strong written and verbal communication skills in English (level A2 CEFR) are essential.
The estimated salary for this position is around $80,000 - $100,000 per year, depending on experience and qualifications.
BenefitsWe offer a range of benefits, including comprehensive health insurance, retirement plans, and opportunities for professional development.
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