10 дней назад
Specialist QC System/Equipment (LIMS)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Specialist QC System/Equipment (LIMS): Supporting and maintaining QC equipment, LIMS, and analytical software in a GMP-regulated biotechnology environment with an accent on system validation, data integrity, and equipment lifecycle management. Focus on implementing QC computerized systems, coordinating cross-functional projects, customizing reports, and translating user requirements into compliant technical solutions.
Location: Yverdon-les-Bains, Switzerland
Company
is a biotechnology company developing and supporting regulated pharmaceutical and life-science solutions.
What you will do
- Lead QC equipment selection through user requirements specifications, and support qualification and lifecycle management.
- Coordinate LIMS enhancements, issue resolution, user acceptance testing, and configuration changes with administrators and global teams.
- Implement and validate QC systems and analytical software, including Empower, SoftMaxPro, and SoloVPE.
- Create and maintain computerized system methods, protocols, reports, and templates within LIMS and related software.
- Support digital reporting and data visualization integrations with Power BI and MES/Skyland.
- Manage deviations, change controls, corrective and preventive actions, audit support, and GxP documentation for QC computerized systems.
Requirements
- Bachelor’s or Master’s degree in life sciences, IT, bioinformatics, or engineering.
- 5–10 years of biotechnology or pharmaceutical industry experience in a GMP-regulated environment.
- Hands-on experience with LIMS, preferably LabWare, and analytical software such as Empower, SoftMaxPro, or SoloVPE.
- Experience with system validation, project coordination, regulatory compliance, and computerized system validation.
- Strong understanding of GMP guidelines, data integrity, LIMS administration, technical configuration, and QC computerized systems.
- Strong written and spoken English is required, including collaboration with US-based teams.
Culture & Benefits
- Cross-functional collaboration with QC, QA, IT, engineering, calibration and qualification teams, vendors, and global stakeholders.
- Ownership of complex QC system topics and opportunities to lead system improvements.
- Work focused on regulatory compliance, operational efficiency, data integrity, and continuous process improvement.
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