Validation Lead

Job Description Validation Lead

Location: Bangalore

Type: Full-Time

Experience: 8+ Years

Role Overview

We are seeking a highly skilled CSV Validation Lead to manage Computer System Validation and compliance governance across our GxP-regulated enterprise applications. The ideal candidate must have strong hands-on experience validating enterprise applications (ERP, MES, LIMS, QMS, cloud/SaaS platforms) and the ability to define and maintain scalable validation frameworks aligned to global regulatory standards.

The role requires deep expertise in CSV, SDLC, data integrity, test strategy, automation readiness, AI/ML system considerations, and non-functional validation. Candidates must be capable of authoring and maintaining validation deliverables in real time, guiding cross-functional teams, and ensuring a continuous state of compliance across large, complex IT environments.

Key Responsibilities

1. CSV Strategy & Governance

• Develop and own the enterprise CSV strategy aligned with GAMP 5, 21 CFR Part 11, EU Annex 11, and global compliance requirements.
• Establish and maintain validation policies, SOPs, templates, VMP, and standards.
• Implement risk-based validation methodologies and ensure consistent application across all IT and business functions.
• Provide strategic oversight on AI/ML-enabled platforms, ensuring validation approaches meet modern compliance expectations.
• Stay up to date with AI and ML regulatory guidelines while building and maintaining the CSV roadmap.
• Conduct periodic system reviews, revalidation assessments, and continuous improvements.

2. Enterprise Application Validation (ERP | MES | LIMS | Cloud/SaaS)

• Lead validation of complex enterprise applications, ensuring adherence to CSV and SDLC best practices.
• Validate large, integrated systems with multiple interfaces, APIs, and data flows.
• Ensure compliance for cloud-hosted and SaaS applications, including vendor qualification and release impact assessment.
• Partner with product and architecture teams to ensure system design supports testability and compliance.

3. Validation Deliverables & Lifecycle Management

• Author, review, and maintain all validation deliverables including:
• URS, FRS/FS, RA, TMX, IQ/OQ/PQ, Test Plans, Test Cases, VSR.
• Ensure real-time upkeep of validation documentation, evidence, traceability, and audit trails.
• Manage validation of upgrades, enhancements, integrations, interfaces, and data migration activities.
• Ensure continuous validated state across on-premise, cloud, and hybrid environments.

4. Data Integrity & Testing

• Lead and conduct Data Integrity assessments (ALCOA+), GAP analysis, remediation, and compliance monitoring.
• Perform SQL-based data testing, data reconciliation, ETL/pipeline validation, and data migration verification.
• Ensure adherence to global DI frameworks and readiness for regulatory scrutiny.

5. Automation, Tools & DevOps Alignment

• Integrate validation activities with DevOps pipelines: Azure DevOps, GitHub Actions, Jenkins, GitLab CI.
• Guide adoption of automated regression testing approaches where applicable.
• Manage ALM/validation tools such as Veeva Vault, TrackWise, QALM/ALM, Jira Test Management, ServiceNow.
• Ensure robust change control, versioning, and configuration management processes.

6. Audit & Regulatory Support

• Lead preparation for internal and external audits (FDA, EMA, global regulatory bodies).
• Act as SME during inspections; provide documentation, evidence, and responses.
• Oversee CAPA, deviations, impact assessments, and remediation plans.

7. Stakeholder & Vendor Management

• Collaborate with IT, QA, Product, Security, and SMEs for validation planning and execution.
• Manage vendor and partner validation deliverables, ensuring compliance with SLAs and contract terms.
• Mentor, guide, and develop validation engineers, analysts, and reviewers.
• Support customers in their validation execution and governance, ensuring alignment with compliance expectations.

Qualifications & Experience

• Bachelor's or Master's in Computer Science, Engineering, Life Sciences, or related disciplines.
• 8+ years of hands-on experience in CSV and IT Validation roles in pharma, biotech, life sciences, or regulated SaaS/enterprise environments.
• Strong expertise in CSV + SDLC, validation documentation, and risk-based testing approaches.
• Hands-on experience with enterprise application validation (ERP, MES, LIMS, QMS, cloud/SaaS systems).
• Strong understanding of AI/ML product testing and compliance considerations.
• Experience supporting global regulatory audits and maintaining validated state across systems.
• Familiarity with API validation, automation concepts, data validation, and test frameworks.

Skills & Attributes

• Strong analytical mindset and attention to detail.
• Excellent cross-functional communication and stakeholder management.
• Strong QA and testing fundamentals, including functional, non-functional, and data validation.
• Ability to work in fast-paced, dynamic, and scaled enterprise environments.
• Experience with cloud (AWS, Azure, GCP) and SaaS validation practices.
• Ability to manage multiple validation programs concurrently.

What We Offer

• Competitive salary with performance-based bonuses
• Comprehensive health and wellness benefits
• Opportunity to work on state-of-the-art technologies in the SaaS domain.
• A vibrant and inclusive work culture emphasizing growth and learning.
• Regular workshops, training sessions, and tech talks

About Mareana

Mareana specializes in Enterprise digital AI products, with an emphasis on Manufacturing, Supply Chain, and Sustainability. Our unique methodology addresses core data challenges, streamlining the digital transformation process and expediting value realization.

We leverage connected data and cutting-edge AI technology to deliver near real-time insights, enabling businesses to adapt swiftly to evolving dynamics. To date, we've contributed over $1 billion in value to our clients who are industry leaders in life sciences, consumer goods, chemicals, food & beverage, and general manufacturing.

Our expanding client base encompasses 3 of the top 10 pharmaceutical firms, 2 leading global medical device companies, and a global leader in consumer health products. Gartner has acknowledged our persistent drive for innovation, dubbing us a Cool Vendor in AI.

Our insights and expertise have also been showcased in Silicon Review and Manufacturing Insights magazine. Our founders and executives boast a wealth of knowledge and experience from the pharma and tech sectors and hold degrees from esteemed institutions like the Indian Institute of Technology (IIT), New York University (NYU), UC Berkeley, and UCLA.