RC-REGULATORY COMPLIANCE-CSV-MES Validation-Senior Professional

EY; Kolkata District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

EY-ER Regulatory Compliance seeks an experienced Validation Consultant to lead Computerized System Validation (CSV) for MES deployments using PAS-X. You will ensure global regulatory compliance (FDA, EMA, MHRA) and drive lifecycle documentation, risk assessments, and audit readiness across multi-site pharma clients.

The role emphasizes strategy, governance, and collaboration with Manufacturing, QA, IT, and global programs to deliver high-quality validation deliverables and continuous improvement.

Qualifications

• Bachelor’s or Master’s degree in Biotechnology, Engineering, or related field.
• 5+ years in CSV/CSA within GMP environments, with MES focus; Werum PAS-X preferred.
• Hands-on validation of integrations with ERP, LIMS, SCADA/PLC, historians.
• Knowledge of regulatory requirements including GAMP 5, 21 CFR Part 11, Annex 11.
• Consulting or client-facing experience preferred.
• Excellent communication, documentation, and stakeholder management skills.

Responsibilities

• Develop end-to-end validation approach for PAS-X implementations.
• Define scope, deliverables, and acceptance criteria for releases.
• Ensure alignment with 21 CFR Part 11, EU Annex 11, and data integrity.
• Own lifecycle documents: URS, FS/DS, IQ/OQ/PQ, Traceability Matrix.
• Coordinate test governance and witness test execution.
• Lead supplier system management and vendor qualification.
• Prepare for audits and inspections; drive continuous improvement.

Skills

CSV/CSA experience

Regulatory compliance

Client-facing

Project leadership

Documentation

Education

Bachelor’s or Master’s degree in Biotechnology/Engineering

Tools

Werum PAS-X

ERP (SAP/Oracle)

LIMS

SCADA/PLC

ISA-95/ISA-88

Job description

Job Summary

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines methodologies. As a Regulatory Compliance Manager actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you will consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The Opportunity

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 PAS-X 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 end-to-end validation approach for PAS-X 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 PAS-X core, master batch record (MBR) configurations, interfaces (e.g., ERP, LIMS, historians, shop-floor devices), and reports. Coordinate and witness test execution, deviations management, defect triage, and formal release decisions.
• Supplier System Management : Lead quality oversight of the PAS-X vendor and implementation partners per supplier qualification processes. Review vendor documentation, leverage vendor testing where appropriate under a risk-based 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 e-signature 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 (on-prem or cloud), databases, and PAS-X 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 error-handling tests.
• Change Release Management : Implement compliant change control, versioning, and release procedures for PAS-X and content. Chair or contribute to CABs, assess impact, and ensure regression testing and re-validation 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.
• Cross-Functional 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

• Bachelor's or Master's degree in Biotechnology, Engineering, or related field.
• 5+ years in Computerized System Validation (CSV/CSA) within GMP environments, with focus on MES; direct experience with Werum PAS-X is strongly preferred.
• Hands-on experience validating integrations with ERP, LIMS, SCADA/PLC, historians , and shop-floor equipment; familiarity with ISA-95/ISA-88.
• Strong understanding of regulatory requirements including GAMP 5 , 21 CFR Part 11 , Annex 11 .
• Consulting or client-facing 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 risk-based 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.