Join EY's Regulatory Compliance team as a Manager specializing in Computerized System Validation (CSV) for Manufacturing Execution Systems (MES) using PAS-X. You will play a pivotal role in defining and executing validation strategies for global pharmaceutical clients, ensuring adherence to stringent regulatory standards. This role offers a unique opportunity to shape transformative initiatives and drive operational excellence within a leading global organization.

This position is ideal for experienced validation professionals seeking to leverage their expertise in a dynamic and collaborative environment. Contribute to building a better working world by ensuring the integrity and compliance of critical systems.

Develop comprehensive validation strategies for PAS-X implementations, including CSV/CSA approaches and risk assessments. Ensure strict adherence to global regulatory standards such as 21 CFR Part 11, EU Annex 11, and data integrity principles. Lead the creation and oversight of essential lifecycle documentation, including URS, FS/DS, IQ/OQ/PQ protocols, and reports. Define and manage test strategies, environments, and execution for PAS-X, its interfaces, and reporting modules. Provide quality oversight for vendors and implementation partners, ensuring compliance with GxP expectations. Validate critical controls for data integrity, security, and electronic records/signatures. Establish standards for validating Manufacturing Batch Records (MBRs) and associated content. Coordinate the qualification of underlying infrastructure and application tiers, adhering to GAMP 5 and ITIL guidance. Drive the validation of integrations with various systems like ERP, LIMS, and SCADA. Implement compliant change control, versioning, and release procedures for PAS-X and its content. Prepare teams and documentation for audits and inspections, driving continuous improvement.

A Bachelor’s or Master’s degree in Biotechnology, Engineering, or a related field is required. Minimum of 8 years of experience in Computerized System Validation (CSV/CSA) within GMP environments, with a strong focus on MES; direct experience with Werum PAS-X is highly preferred. Demonstrated hands-on experience validating integrations with ERP, LIMS, SCADA/PLC, historians, and shop-floor equipment is essential. A deep understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, Annex 15, data integrity, ICH Q9/Q10, and relevant regional guidance is mandatory. Familiarity with ISA-95/ISA-88 standards and consulting or client-facing experience is advantageous. Exceptional communication, documentation, and stakeholder management skills are crucial for success in this role.