Lead CSV/C&Q Architect for GMP Data Hub

Panda International

Basel

On-site

CHF 120,000 - 160,000

Full time

15 hours ago

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Job summary

Panda International in Basel, Switzerland is seeking an E2E CSV/C&Q Lead for the Operations Data Hub on a 12-month contract. The role focuses on owning the end-to-end validation approach to enable GMP-relevant decision-making within the digital manufacturing program.

You will build and own the integrated validation framework, drive lighthouse-site validation, and ensure traceability, data integrity and ALCOA+ compliance across ISA-95 layers while coordinating IT/OT, Automation, Engineering and

Qualifications

Bachelor’s or Master’s in Engineering, Automation, Computer Science, IT, Life Sciences or related.
Proven experience delivering end-to-end CSV/C&Q strategies for integrated IT/OT systems.
Strong knowledge of GMP, CSV/CSA, change control, deviations and CAPA.
Broad understanding of automation, MES, historians and integration platforms.

Responsibilities

Build and own the integrated, risk-based CSV/C&Q strategy for ODH Phase 1.
Coordinate validation delivery for the lighthouse site deployment.
Define qualification approaches for data products like Batch Traceability and Process Monitoring.
Ensure end-to-end traceability, data integrity and ALCOA+ compliance across ISA-95 layers.
Shape supplier assurance and vendor-testing reliance strategy.
Create reusable validation blueprint and cost model for future rollouts.
Align Business, IT/OT, Automation, Engineering, Quality and partners around one validation framework.