E2E CSV/C&Q Lead - Associate Director, Engineering

SGI; Basel; On-site; CHF 140,000 - 210,000; Full time

Job summary

SGI seeks an experienced E2E CSV/C&Q Lead to define, coordinate, and deliver the integrated qualification and validation strategy for a large-scale Operations Data Hub program in Basel. The role ensures a compliant, risk-based, scalable validation approach across IT, OT, automation, and data platforms.

You will lead validation activities, establish reusable frameworks, ensure traceability and data integrity, and align with Quality, IT, and Business stakeholders to support global deployment and

Qualifications

• Strong experience leading end-to-end CSV and qualification activities across IT/OT environments.
• Deep knowledge of GMP, CSV/CSA, C&Q, data integrity, ALCOA+ and risk-based validation.
• Proven ability to manage requirements, traceability, risk assessments, and validation docs.

Responsibilities

• Define, coordinate, and deliver the integrated CSV/C&Q strategy for the program.
• Lead qualification and validation activities supporting production deployment.
• Ensure traceability, validation evidence, testing, data integrity, and release readiness.
• Collaborate with Quality, IT/OT, Engineering and external partners to unify validation.

Skills

End-to-end CSV

Validation leadership

Stakeholder management

GxP / GMP knowledge

Data integrity

Education

Bachelor's or Master's in Engineering or Life Sciences

Job description

SGI seeks an experienced E2E CSV/C&Q Lead to define, coordinate, and deliver the integrated qualification and validation strategy for a large-scale Operations Data Hub program in Basel. The role ensures a compliant, risk-based, scalable validation approach across IT, OT, automation, and data platforms.

You will lead validation activities, establish reusable frameworks, ensure traceability and data integrity, and align with Quality, IT, and Business stakeholders to support global deployment and