Full-Time
Validation Consultant Senior
Multiple Teams
Ernst & Young
5,001-10,000 employees
Global professional services: consulting, assurance, tax
No salary listed
Kolkata, West Bengal, India
In Person
Bachelor's, Master's
 Legal & Compliance (1) |
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- A Bachelor's or Master's degree in Biotechnology, Engineering, or a related field is required.
- At least 5 years of Computerized System Validation or Computerized System Assurance experience in Good Manufacturing Practice environments, focused on Manufacturing Execution Systems, is required.
- Hands-on experience validating integrations with Enterprise Resource Planning systems, Laboratory Information Management Systems, Supervisory Control and Data Acquisition or Programmable Logic Controller systems, historians, and shop-floor equipment is required.
- Familiarity with ISA-95 and ISA-88 is required.
- Strong understanding of GAMP 5, 21 CFR Part 11, and EU Annex 11 is required.
- Deep knowledge of Annex 15, data integrity, ICH Q9/Q10, and relevant regional regulatory guidance is required.
- Experience producing Gap Analysis, User Requirements Specifications, Functional Requirements Specifications, Installation/Operational/Performance Qualification documentation, Risk Assessments, Traceability Matrices, and Validation Plans is required.
- Familiarity with Computer Software Assurance principles and risk-based testing is required.
- Experience working in Agile delivery models is required.
- Understanding of PAS-X architecture, including electronic Batch Record, Master Batch Record design, Weigh & Dispense, Track & Trace, KPI/Reporting modules, and configuration lifecycle, is required.
- Competence with test management tools such as ALM, Jira, or Xray and document management in an electronic Quality Management System is required.
- Knowledge of databases, networking, virtualization or cloud platforms such as AWS or Azure, and cybersecurity controls relevant to Manufacturing Execution Systems is required.
- Strong stakeholder management and client-facing skills are required.
- Strong project management, problem-solving, and communication skills are required.
- Develop the end-to-end validation approach for PAS-X implementations, including Computerized System Validation or Computerized System Assurance strategy, risk assessments, and the validation master plan or equivalent documents aligned with the corporate Quality Management System and current Good Practice expectations.
- Define scope, deliverables, and acceptance criteria for releases and site deployments.
- Ensure alignment with global regulatory standards, including FDA, EMA, and MHRA requirements, and translate regulatory changes into updates to validation practices.
- Author or oversee lifecycle documents including User Requirements, Functional or Design Specifications, Configuration Specifications, Risk Assessments, Installation/Operational/Performance Qualification protocols and reports, Traceability Matrices, Data Migration and Interface Validation documentation, and periodic review plans.
- Define test strategy and environments for PAS-X core, Master Batch Record configurations, interfaces, and reports.
- Coordinate and witness test execution, deviation management, defect triage, and formal release decisions.
- Lead quality oversight of the PAS-X vendor and implementation partners in accordance with supplier qualification processes.
- Review vendor documentation and ensure adequate evidence for audits and inspections.
- Validate user management, electronic records and signatures, audit trails, backup and restore, time synchronization, and segregation of duties.
- Confirm controls for recipe and Master Batch Record versioning, electronic batch record review, exception handling, and electronic-signature workflows.
- Establish standards and procedures for validating Master Batch Records, libraries, and parameter sets.
- Ensure design reviews, simulation runs, and test data reflect representative production scenarios and critical process parameters.
- Coordinate qualification of on-premises or cloud infrastructure, databases, and PAS-X application tiers following ITIL, DevOps, and GAMP 5 guidance.
- Oversee change control for configuration items, patches, and upgrades.
- Drive validation of integrations with Enterprise Resource Planning, Laboratory Information Management Systems, warehouse and dispensing systems, labeling, serialization, Supervisory Control and Data Acquisition or Programmable Logic Controller systems, and historians.
- Implement compliant change control, versioning, and release procedures for PAS-X and its content.
- Chair or contribute to Change Advisory Boards, assess impact, and ensure regression testing and risk-appropriate revalidation.
- Prepare teams and documentation for internal audits and health authority inspections.
- Lead responses to observations and corrective and preventive actions and drive continuous improvement in validation processes.
- Collaborate with Manufacturing, Quality Assurance, Quality Control, Information Technology/Operational Technology, Engineering, Digital, and site or global program teams.
- Provide coaching on Computerized System Validation and Computerized System Assurance principles and mentor validation engineers and testers.
- Direct experience with Werum PAS-X is strongly preferred.
- Consulting or client-facing experience is preferred.
- Exposure to business development activities and client engagement strategies.
- Awareness of artificial intelligence and machine learning use in regulated environments and related quality or governance considerations.
- Ability to align technology with business transformation goals.
- Familiarity with emerging regulatory trends, including Computer Software Assurance and digital validation approaches.
- Certified Software Quality Engineer or Certified Software Quality Assurance certification.
- ISO 9001:2015 Lead Auditor or Quality Auditor Certification.
- PAS-X vendor training or certification, or equivalent Manufacturing Execution System credentials.
- Information Security or Risk Management certifications.
EY (Ernst & Young) provides professional services at a global scale, offering consulting, assurance, tax, and transaction advisory services. It serves clients across industries such as technology, media, real estate, hospitality, and construction. Instead of selling a single product, EY works with clients through tailored engagements where cross-disciplinary teams analyze challenges, design strategies, perform audits, help with tax planning, and assist with mergers or divestitures. What sets EY apart is its worldwide reach and integrated service model, industry-specific expertise, and focus on responsible business practices like sustainability, cybersecurity, and workforce flexibility. EY’s goal is to help organizations improve performance, manage risk, and achieve sustainable growth while building a better working world.
Company Size
5,001-10,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Boston, Massachusetts
Founded
1991
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See people who can refer or advise you
Simplify's Take
What believers are saying
- EY.ai Agentic for Sales launched March 2, 2026, broadening AI-led revenue opportunities.
- EY's Copilot rollout reached 150,000 users, boosting productivity 15 percent for client delivery.
- EY's Snowflake Innovation Center, launched February 10, 2026, deepens cloud-data transformation partnerships.
What critics are saying
- EY paid £105.5 million to settle NMC Health claims on May 18, 2026.
- EY faces Shell audit probes; four partners left after December 2025 rotation breaches.
- EY cut 3,000 U.S. jobs in 2025, signaling overcapacity and partner-client pressure.
What makes Ernst & Young unique
- EY Canvas now embeds agentic AI across 160,000 audits in 150 countries.
- EY and Microsoft invested over $1 billion on May 21, 2026, for enterprise AI.
- EY bought Supply Nexus on May 12, 2026, strengthening supply-chain automation and AI consulting.
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Benefits
Professional Development Budget
Flexible Work Hours
Remote Work Options
Company News
EY has introduced an "invisible" AI router to manage internal AI spending, helping cut token consumption by up to 60% since its April rollout. The router sits behind specialised AI tools and directs employee queries to the most appropriate model for each task, rather than defaulting to the most powerful option. Token costs have become a growing concern as AI providers increasingly charge based on usage. EY's AI Pulse survey found that 82% of senior leaders at companies investing in AI were worried about token usage. The router has been deployed on department-specific platforms, including tax and risk functions, though not on the general Microsoft Copilot chatbot available to all staff. EY has also implemented token budgets based on employees' roles and departments. The firm's global consulting AI leader Dan Diasio said companies should focus AI investment on areas with the deepest impact rather than spreading resources thinly.
The UK's Financial Reporting Council has fined EY nearly £1.2m and audit partner Julie Carlyle £49,000 for failings in their 2021 audit of Made.com. Both received severe reprimands for breaching international auditing standards regarding going concern and deferred tax assets. The FRC said the auditors relied on management forecasts without sufficient challenge or adequate testing. Made.com, an online furniture retailer that listed on the London Stock Exchange in June 2021, entered administration in November 2022 after reporting a £35.3m loss. EY later disclaimed its opinion on Made.com's 2022 interim statements due to material uncertainty about the company's ability to continue operating.
Australia's securities regulator is reviewing internal and whistleblower complaints about audit conduct at all Big Four accounting firms. The Australian Securities and Investments Commission will examine allegations of misuse or sharing of confidential information at PwC, Deloitte, EY and KPMG. The review follows multiple scandals, including PwC Australia's 2023 tax leaks case, where a former partner disclosed confidential government information about multinational tax avoidance laws. KPMG Australia recently revealed that more than two dozen employees, including one partner fined A$10,000, used AI to cheat on internal training exams. Meanwhile, Deloitte's latest workforce survey in New Zealand indicates younger professionals are becoming more selective about careers in public accounting.
Trinidad and Tobago has signed agreements with two US companies to develop data centres in the Caribbean nation. The memorandums of understanding with Florida-based Hummingbird AI Holdings and New York's Ernst and Young were signed on Friday, marking the first such deals with a Caribbean country. Ernst and Young will develop a 300-megawatt data centre, whilst Hummingbird AI Holdings plans a 150MW AI infrastructure facility. The government said the initiatives could generate over 5,000 jobs. However, the deals have sparked environmental concerns. Social activist Dr Wayne Kublalsingh criticised the energy consumption plans, whilst water-intensive data centres could strain Trinidad and Tobago's already stretched water supply system.
EY has sacked two staff members who allegedly accessed Australian Prime Minister Anthony Albanese's bank account details whilst working on a contract for Commonwealth Bank. The bank has not commented on how the contractors accessed such sensitive information. The incident means all Big Four consultancies now face scrutiny in Australia. KPMG's chair recently departed after inappropriate use of client data, whilst Deloitte repaid fees for submitting an AI-generated report. PWC faced the most serious scandal, using knowledge gained from tax policy consultations to advise tech companies on reducing tax payments. EY, formerly Ernst and Young, has not disclosed further details about the alleged breach or the circumstances surrounding the access to the Prime Minister's banking information.