Senior CSV and Data Integrity Engineer

Our client, a leading biotechnology organization, is seeking a Subject Matter Expert to lead commissioning and qualification activities for computer systems. This role focuses on ensuring that data integrity and validation standards are met for a major international capital expenditure project.

• Act as the subject matter expert and compliance lead for CSV and Data Integrity throughout the project lifecycle from design to reporting.
• Drive the CSV portion of the project, ensuring all commissioning and qualification activities are completed in compliance with system requirements and project guidelines.
• Execute Data Integrity Risk Assessments (DIRA) and perform comprehensive gap analyses for equipment and systems.
• Oversee 21 CFR Part 11 compliance aspects, including audit trails, electronic signatures, system security, and access management.
• Collaborate with IT and automation specialists to ensure correct implementation and testing of PLC, SCADA, and DCS systems.
• Draft and coordinate the review of CSV technical documentation, including requirements, testing protocols, and summary reports.
• Manage verification testing, lead deviation investigations, and resolve technical issues encountered during execution activities.

• You have a Bachelor or Master degree in Engineering or a related technical qualification.
• You bring 5+ years of experience as a Lead or Subject Matter Expert in international CAPEX Commissioning and Qualification.
• You possess extensive knowledge of CSV within the pharmaceutical or biotechnology industry, including risk-based approaches.
• You have a deep understanding of GAMP-5, Annex 15, Eudralex, and ASTM E2500 standards.
• You bring technical expertise in Data Integrity and process automation systems such as DCS, SCADA, and PLC.
• You're a strong leader with the ability to make decisions under pressure and collaborate effectively with senior stakeholders.
• You are fluent in English.

Nice to Haves

• Experience with sterile, biotech, or single-use equipment.
• Familiarity with electronic validation execution.

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
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• Grijp kansen op elk niveau, van een sterke start tot doorgroeimogelijkheden en samenwerking met experts.