E2E CSV/C&Q Lead

Swisslinx AG; Zürich; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

CSV/CSA

GMP

Risk-based validation

Validation documentation

Requirements traceability

Stakeholder management

Data integrity ALCOA+

IT/OT collaboration

English business fluency

Ausbildung

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

Tools

MES

Historians

Data platforms

Jobbeschreibung

Location: Basel, Switzerland (project scope includes Portsmouth, UK)
Start Date: 1 November 2026
Contract Duration: Until 31 October 2027
Lead end-to-end computerised system validation and qualification for an innovative manufacturing data pl

E2E CSV/C&Q Lead

Job description:

We are seeking an experienced E2E CSV/C&Q Lead to take ownership of the end-to-end validation and qualification strategy for a strategic Operations Data Hub (ODH) programme.

The position covers integrated manufacturing systems, IT/OT interfaces, infrastructure, semantic data models, data products and operational applications. You will collaborate with Engineering, Automation, Quality, IT/OT and business stakeholders to ensure that solutions meet regulatory, quality and data integrity requirements.

Your key responsibilities will include:

• Define, implement and maintain an integrated, risk-based Computerised System Validation (CSV) and Commissioning & Qualification (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 relevant GMP requirements.
• Prepare and coordinate validation documentation for independent Quality review and approval.
• Define supplier assurance strategies, including the use of vendor testing and previously qualified components.
• Ensure that 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, manage validation dependencies and elevate programme-level compliance risks.
• Support release readiness assessments and coordinate with business and Quality stakeholders throughout implementation.

About the customer:

Our client is an internationally established organisation within the pharmaceutical and biotechnology sector, specialising in complex, highly regulated manufacturing operations. As part of its digital transformation initiatives, the organisation is implementing advanced manufacturing data solutions to improve connectivity, traceability and operational efficiency across production environments.

Requirements:

• Bachelor's or Master's degree in Engineering, Automation, Computer Science, IT, Life Sciences, Pharmaceutical Sciences, Quality Management or a related discipline.
• 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.
• Solid expertise in validation documentation, requirements traceability, testing strategies and supplier assurance.
• Strong understanding of data integrity principles, including ALCOA+.
• Knowledge of manufacturing automation environments, MES, historians, system interfaces, infrastructure and data transformations.
• Experience collaborating with Quality, Engineering, Automation, IT/OT and external suppliers.
• Ability to develop pragmatic, risk-based validation strategies while maintaining regulatory compliance.
• Strong coordination, communication, stakeholder management and problem-solving skills.
• Business-fluent English.

Nice to Have

• Previous validation leadership experience within pharmaceutical or biotechnology manufacturing.
• Experience with enterprise-wide manufacturing data integration or digitalisation initiatives.
• Familiarity with ISA-95 architecture and complex manufacturing data flows.
• Experience developing reusable qualification frameworks for multi-site deployments.
• Exposure to validation of data platforms, semantic data models and manufacturing analytics applications.