CSV Expert

Randstad is seeking a highly experienced Subject Matter Expert (SME) in Computerized System Validation (CSV) to support our client, a leading pharmaceutical company in the Basel area. You will provide critical expertise across Production, Quality Control (QC), and IT systems (e.g., eQMS, LIMS, ERP). This role is key to ensuring system validation, regulatory compliance, and lifecycle management aligned with GAMP 5 guidelines and data integrity standards.

Key Responsibilities

Validation & Compliance

• Lead or support the development of user and functional requirements for new systems.

• Contribute to system design and ensure validation and qualification activities (IQ/OQ/PQ) are in compliance with regulatory expectations.

• Author, review, and approve CSV documentation: validation plans, protocols, test cases, reports.

• Perform or supervise verification tests, assess deviations, and implement corrective actions.

• Ensure ongoing compliance of systems throughout their lifecycle (change control, periodic reviews, etc.).

Cross-functional Collaboration

• Participate in project planning and cross-functional teams as CSV expert.

• Evaluate system prototypes and ensure CSV coverage during system demos and testing phases.

• Support system owners and process owners during audits and regulatory inspections.

• Interface with vendors and external stakeholders on validation activities.

System Support & Continuous Improvement

• Provide ongoing technical guidance to ensure system reliability and compliance.

• Identify improvement opportunities and support system upgrades and optimizations.

• Analyze user and audit feedback and integrate enhancements into CSV processes.

• Train internal stakeholders on CSV best practices and compliance requirements.

Your Profile

Technical Expertise

• At least 10 years of hands-on experience in CSV across production and lab systems.

• Deep knowledge of GAMP 5, Data Integrity principles, and regulatory expectations.

• Strong understanding of cloud-based systems and related validation strategies.

• Experience with ERP, MES, SCADA, LIMS, eQMS, and Trackwise is highly desirable.

• Familiarity with Agile methodologies is a plus.

Languages

• Fluent in English (written and spoken).

• Proficiency in German (reading and reviewing technical documentation).

• French knowledge is a plus.

Soft Skills

• Independent, structured, and solution-oriented mindset.

• Excellent communication skills and ability to influence across departments.

• Strong team player with a pragmatic, collaborative, and proactive approach.

• Able to prioritize and manage multiple projects in a dynamic environment.

• Pedagogical approach when training or supporting colleagues in CSV-related topics.

Interested?
This is a long-term contract opportunity (via Randstad) with a renowned pharmaceutical client. If you’re ready to bring your CSV expertise to a highly impactful role in a regulated environment, we look forward to receiving your application.