Senior Consultant

CSV & Data Integrity (DI) Squad Lead – Geel, Belgium Are you an experienced CSV professional with a strong background in industrial systems and a strategic mindset? We're seeking a CSV & DI Squad Leadto drive excellence in computer system validation and data integrity at a leading pharmaceutical manufacturing site in Geel. Location:Geel, Belgium 12 months contract Key Responsibilities: Lead the development and execution of a comprehensive CSV strategy, including a robust CSV Master Plan, risk-based testing (GAMP 5), and full lifecycle documentation (DQ, IQ, OQ, PQ). Ensure computerized systems (e.g., PLC, SCADA, PI) are validated and compliant with GxP standards, meeting regulatory expectations for data integrity and product safety. Champion ALCOA++ principles and data integrity practices across the site. Oversee multiple projects and contractor teams, ensuring delivery against plan and compliance with internal and external regulations. Collaborate closely with QA and process owners to align on quality and compliance goals. Drive human and change management initiatives to embed sustainable CSV & DI practices. Coach and mentor Local Process Owners (LPOs) to elevate their capabilities to industry best practice levels. Qualifications & Experience: Minimum 5–7 years of hands-on experience in CSV within the pharmaceutical industry, ideally in an API manufacturing environment. Strong familiarity with industrial systems such as DeltaV, PI, PCS7, and effective alarm management. Deep understanding of FDA and EMA regulatory requirements for CSV and data integrity. Proven experience implementing risk-based validation approaches and authoring validation documentation. Demonstrated leadership experience in dynamic, cross-functional environments. Skilled in project management, stakeholder engagement, and influencing without authority. Excellent communication, coaching, and training capabilities. Language: English (required), Dutch (required) Education: Master's degree or equivalent in a relevant field