E2E CSV/C&Q Validation Lead (12‑Month Contract)

Coopers Group; Basel; On-site; CHF 120,000 - 160,000; Full time

Job summary

Coopers Group in Basel, Switzerland seeks a professional to lead the validation strategy for an integrated CSV/CSA solution within a GMP environment. The role focuses on defining use cases, boundaries, and validation principles across diverse source systems and platforms.

The candidate should have strong IT/OT experience, data integrity knowledge, and the ability to coordinate cross-functional teams including Business, Quality, IT, OT and external partners.

Qualifications

• Must have experience developing end-to-end validation strategies for GxP systems.
• Strong knowledge of ALCOA+, data integrity, and risk-based validation.
• Experience in IT/OT environments including MES, historians, and integration platforms.
• Ability to align Business, Quality, IT, OT, Engineering and partners.

Responsibilities

• Develop and maintain a modular CSV/CQ validation strategy for a connected manufacturing data solution.
• Define use cases, GxP boundaries, system classifications and validation principles across source systems.
• Establish reusable validation framework for initial implementation and future deployments.
• Coordinate qualification activities for production deployment across multiple stakeholders.
• Ensure traceability, testing coverage, validation evidence, data integrity and release readiness.
• Coordinate validation deliverables with Business, Engineering, Automation, IT, OT, Quality and partners.
• Define qualification approaches for batch traceability, process monitoring and data sharing.
• Assess data lineage, transformations, interfaces, access controls and data-integrity risks.

Skills

GxP validation

Data integrity

Risk-based validation

IT/OT environments

Requirements management

Traceability matrices

ALCOA+ principles

Stakeholder alignment

Education

Bachelor’s or Master’s degree in Engineering/CS/IT/Life Sciences/QA

Job description

Coopers Group in Basel, Switzerland seeks a professional to lead the validation strategy for an integrated CSV/CSA solution within a GMP environment. The role focuses on defining use cases, boundaries, and validation principles across diverse source systems and platforms.

The candidate should have strong IT/OT experience, data integrity knowledge, and the ability to coordinate cross-functional teams including Business, Quality, IT, OT and external partners.