Senior CSV/MES Validation Consultant

Job Summary

We are seeking an experienced Validation Consultant Computerized System Validation (CSV) to lead validation and compliance for defining and executing the validation strategy for Manufacturing Execution System (MES) deployments using PASX across regulated and business critical computerized systems for global pharmaceutical clients. The ideal candidate will ensure compliance with global regulatory standards (FDA, EMA, MHRA) and drive strategic initiatives for business process transformation and operational excellence.

Your Key Responsibilities

• Validation Strategy & Planning: Develop the endtoend validation approach for PASX implementations, including CSV/CSA strategy, risk assessments, and the validation master plan or equivalent documents aligned to corporate QMS and current GxP expectations. Define scope, deliverables, and acceptance criteria for releases and site deployments.
• Regulatory Compliance: Ensure alignment with 21 CFR Part 11, EU Annex 11, Annex 15, ICH Q9/Q10, data integrity principles (ALCOA+), and applicable regional guidance. Monitor regulatory changes and translate them into pragmatic updates to validation practices.
• Lifecycle Documentation: Own and author or oversee key lifecycle documents: User Requirements (URS), Functional/Design Specifications (FS/DS), Configuration Specifications, Risk Assessments (FMEA/HAZOP where applicable), IQ/OQ/PQ protocols and reports, Traceability Matrices, Data Migration and Interface Validation, and periodic review plans.
• Test Governance & Execution: Define test strategy and environments for PASX core, master batch record (MBR) configurations, interfaces (e.g., ERP, LIMS, historians, shopfloor devices), and reports. Coordinate and witness test execution, deviations management, defect triage, and formal release decisions.
• Supplier & System Management: Lead quality oversight of the PASX vendor and implementation partners per supplier qualification processes. Review vendor documentation, leverage vendor testing where appropriate under a riskbased model and ensure adequate evidence for audits and inspections.
• Data Integrity & Security Controls: Validate user management, electronic records/signatures, audit trails, backup/restore, time synchronization, and segregation of duties. Confirm controls for recipe/MBR versioning, electronic batch record (eBR) review, exception handling, and esignature workflows.
• MBR/Content Validation: Establish standards and procedures for validating MBRs, libraries, and parameter sets. Ensure design reviews, simulation runs, and test data reflect representative production scenarios and critical process parameters.
• Infrastructure & Platform Qualification: Coordinate qualification of underlying infrastructure (onprem or cloud), databases, and PASX application tiers following ITIL/DevOps and GAMP 5 guidance. Oversee change control for configuration items, patches, and upgrades.
• Interfaces & Automation: Drive validation of integrations with ERP (SAP/Oracle), LIMS, warehouse/dispensing, labeling, serialisation, Scada/plc, and historians using standardized patterns, message catalogs, and errorhandling tests.
• Change & Release Management: Implement compliant change control, versioning, and release procedures for PASX and content. Chair or contribute to CABs, assess impact, and ensure regression testing and revalidation are commensurate with risk.
• Audit/Inspection Readiness: Prepare teams and documentation for internal audits and health authority inspections. Lead responses to observations and CAPAs, and drive continuous improvement in validation processes.
• CrossFunctional Leadership: Collaborate closely with Manufacturing, QA, QC, IT/OT, Engineering, Digital, and Site/Global Program teams. Provide coaching on CSV/CSA principles and mentor validation engineers and testers.

Qualifications

• Bachelors or Masters degree in Biotechnology, , Engineering, or related field.
• 5+ years in Computerized System Validation (CSV/CSA) within GMP environments, with focused on MES; direct experience with Werum PASX is strongly preferred.
• Hands-on experience validating integrations with ERP, LIMS, SCADA/PLC, historians, and shopfloor equipment; familiarity with ISA95/ISA88.
• Strong understanding of regulatory requirements including, GAMP 5, 21 CFR Part 11, Annex 11
• Consulting or clientfacing experience preferred.
• Excellent communication, documentation, and stakeholder management skills.

Must-Have Skills & Attributes

• Deep understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, Annex 15, data integrity, ICH Q9/Q10, and relevant regional guidance.
• Strong Expertise in CSV/CSA documentation: Gap Analysis, URS, FRS, IQ/OQ/PQ, Risk Assessments, Traceability Matrix, Validation Plans. Familiarity with CSA principles and riskbased testing.
• Experience working in Agile delivery models
• Understanding of PAS X architecture, modules (eBR, MBR design, Weigh & Dispense, Track & Trace, KPI/Reporting), and configuration lifecycle.
• Competence in test management tools