E2E CSV/C&Q Lead for Manufacturing Data Platform

Swisslinx AG; Zürich; On-site; CHF 110,000 - 160,000; Full time

Job summary

Swisslinx AG seeks an experienced E2E CSV/CQ Lead to own the end-to-end validation and qualification strategy for a strategic Operations Data Hub program in Basel. You will coordinate validation across integrated manufacturing systems, IT/OT interfaces, infrastructure and data products with Engineering, Quality and IT/OT stakeholders to ensure regulatory compliance and data integrity.

You will develop modular qualification frameworks, implement risk-based validation approaches and oversee

Qualifications

• Proven experience leading end-to-end CSV/C&Q activities for integrated IT/OT systems, manufacturing data platforms or regulated operational applications.
• Strong understanding of GMP, CSV/CSA, Commissioning & Qualification and risk-based validation methodologies.
• Practical experience managing change control, deviations, CAPA and maintenance of the validated state.

Responsibilities

• Define, implement and maintain an integrated, risk-based CSV and C&Q strategy.
• Establish validation boundaries, intended use, GxP classifications and appropriate controls across the manufacturing data platform.
• Develop modular qualification frameworks, documentation standards and reusable validation approaches for future implementations.
• Coordinate end-to-end validation execution, including requirements traceability, testing, documentation and release readiness.
• Define validation approaches for operational applications supporting batch traceability, process monitoring and customer data sharing.
• Evaluate data integrity, data lineage, interoperability and auditability across integrated manufacturing systems.
• Ensure alignment with ALCOA+ principles and GMP requirements.
• Prepare and coordinate validation documentation for independent Quality review and approval.
• Define supplier assurance strategies, including vendor testing and previously qualified components.
• Ensure validated-state maintenance requirements are incorporated into operational support processes.
• Develop qualification templates, implementation prerequisites and resource, cost and timeline estimates for future site rollouts.
• Facilitate cross-functional risk assessments and elevate programme-level compliance risks.

Skills

CSV/CSA

GMP

Risk-based validation

Validation documentation

Requirements traceability

Stakeholder management

Data integrity ALCOA+

IT/OT collaboration

English business fluency

Education

Bachelor's or Master's in Engineering/Automation/CS/IT/Life Sciences/Pharma

Tools

MES

Historians

Data platforms

Job description

Swisslinx AG seeks an experienced E2E CSV/CQ Lead to own the end-to-end validation and qualification strategy for a strategic Operations Data Hub program in Basel. You will coordinate validation across integrated manufacturing systems, IT/OT interfaces, infrastructure and data products with Engineering, Quality and IT/OT stakeholders to ensure regulatory compliance and data integrity.

You will develop modular qualification frameworks, implement risk-based validation approaches and oversee