QC Systems & LIMS Expert - Validation & Data Integrity

Incyte; Yverdon-les-Bains; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Incyte is seeking a QC Equipment and System Specialist to support and maintain QC systems, with emphasis on LIMS (LabWare) and analytical software. You will lead validation, data integrity efforts, and cross-functional projects across QC, QA, IT, and global teams.

You will drive equipment lifecycle management, software implementations (Empower, SoftMaxPro, SoloVPE), and regulatory documentation while ensuring GMP compliance and robust reporting.

Qualifikationen

• Bachelor's or Master’s degree in life sciences, IT, bioinformatics, or engineering.
• 5–10 years of experience in biotech/pharma GMP-regulated environments.
• Hands-on experience with LIMS (LabWare) and analytical software (Empower, SoftMaxPro, SoloVPE).
• Experience in system validation, project coordination, and regulatory compliance.

Aufgaben

• Lead QC equipment selection via URS creation, support equipment qualification and lifecycle management and interface with internal stakeholders (Quality operations, Engineering, Calibration/Qualification).
• Coordinate with LIMS administrators and global teams to support system enhancements, issue resolution, and UAT reviews.
• Act as a key contributor in LIMS-related projects including new equipment and software implementations (Empower, SoftMaxPro, SoloVPE, …), from requirement gathering to technical execution and validation.
• Lead or support validation of computerized systems including URS creation, protocol development, execution, and compliance documentation.
• Create, manage and maintain computerized systems methods and protocols.
• Actively lead and participate to QC digital/computerized projects and improvement (e.g. Custom Fields validation, Excel file validation)
• Interface with digital reporting systems (e.g., Power BI, MES/Skyland) to support integration and data visualization needs.
• Manage and maintain reports and templates within LIMS and related software to meet QC operational needs.
• Support deviation investigations, change control (CC), and GxP documentation updates related to QC computerized systems.
• Drive implementation of streamlined new processes within LIMS according to project timelines.
• Ensure compliance of LIMS UAT processes and configuration changes.
• Liaise with stakeholders (QA, QC, IT, vendors) to ensure cross-functional alignment on system functionalities and regulatory compliance.
• Act as the QC system SME during internal and external audits, providing technical documentation and explanations.
• Proactively identify system improvement opportunities and lead corrective/preventive actions related to QC systems.

Kenntnisse

LIMS administration

CSV validation

GxP compliance

Project coordination

English communication

Ausbildung

Bachelor's or Master's in life sciences/IT/bioinformatics/engineering

Tools

LabWare

Empower

SoftMaxPro

SoloVPE

Jobbeschreibung

Incyte is seeking a QC Equipment and System Specialist to support and maintain QC systems, with emphasis on LIMS (LabWare) and analytical software. You will lead validation, data integrity efforts, and cross-functional projects across QC, QA, IT, and global teams.

You will drive equipment lifecycle management, software implementations (Empower, SoftMaxPro, SoloVPE), and regulatory documentation while ensuring GMP compliance and robust reporting.