CSV & C&Q Lead

Panda International; Basel; On-site; CHF 120,000 - 160,000; Full time

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.

Skills

CSV/C&Q strategy

GMP knowledge

Data integrity

Automation & MES

Validation governance

Education

Bachelor’s or Master’s in Engineering/IT/Life Sciences

Tools

ISA-95

Validation frameworks

Job description

Now hiring: E2E CSV/C&Q Lead | Operations Data Hub

Basel, Switzerland | 12-month contract (1 Nov 2026 - 31 Oct 2027) | Full-time, 41 hrs/week

I’m partnering with a leading life sciences manufacturer on a lead role at the center of their digital manufacturing program.

Their Operations Data Hub (ODH) connects manufacturing source systems, OT/IT integrations, platform services, data products and operational applications. They need someone to own the end-to-end validation approach that gets it ready to support GMP-relevant decision-making.

What you’ll do:

• Build and own the integrated, risk-based CSV/C&Q strategy for ODH Phase 1
• Coordinate validation delivery for the first “lighthouse” site deployment, through to release readiness
• Define the qualification approach for data products like Batch Traceability, Process Monitoring and Customer Data Sharing
• Ensure end-to-end traceability, data integrity and ALCOA+ compliance across the connected ISA-95 layers
• Shape the supplier assurance and vendor-testing reliance strategy
• Create a reusable validation blueprint, qualification archetypes and effort/cost model for future site rollouts
• Align Business, IT/OT, Automation, Engineering, Quality and external partners around one validation framework

What you bring:

• Bachelor’s or Master’s in Engineering, Automation, Computer Science, IT, Life Sciences, Pharmaceutical Sciences, Quality Management or similar
• Proven experience developing and coordinating E2E CSV/C&Q strategies for integrated systems spanning IT, OT, data platforms and applications
• Strong knowledge of risk-based validation, GMP, CSV/CSA, C&Q, change control, deviations and CAPA
• Broad understanding of automation, MES, historians, integration platforms and their validation implications
• Practical data integrity experience: data lineage, interfaces, auditability and access controls
• A pragmatic mindset, keeping things compliant and defensible without unnecessary documentation or duplicated testing

Why this one stands out: you won’t just validate a system. You’ll set the validation standard that future sites and growth projects are built on.

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