Job Description

About Infiligence
Infiligence is a specialized IT services firm serving the global life sciences sector-from digital health innovators to Big Pharma. We deliver DevOps, Modernization, CSV/QE, and Integration services to clients navigating complex regulatory landscapes across FDA, EMA, and global GxP requirements. The Opportunity
Join our growing Chennai validation practice supporting North American life science clients. You'll work on mission-critical systems for pharmaceutical, biotech, medical device, and digital health companies-ensuring patient safety and regulatory compliance through rigorous validation practices. What You'll Do
Validation Lifecycle Leadership

• Author, review, and execute validation lifecycle documentation (VP, URS, FS, DS, IQ/OQ/PQ, Summary Reports)
• Develop and maintain Requirements Traceability Matrices (RTM) and Risk Assessments
• Lead validation activities for clinical, manufacturing, laboratory, and quality systems

Compliance & Quality Assurance

• Ensure strict adherence to FDA 21 CFR Part 11, EU Annex 11, GxP, and GAMP 5 principles
• Apply risk-based validation approaches per GAMP 5 categorization
• Perform gap assessments and develop remediation plans for legacy systems

Audit & Regulatory Support

• Support client audits (internal, vendor, regulatory inspections)
• Prepare validation evidence packages for regulatory submissions (FDA, EMA, MHRA)
• Respond to FDA 483 observations and CAPA implementations related to CSV

Collaboration & Knowledge Sharing

• Collaborate across time zones with global project teams and client stakeholders
• Mentor junior validation engineers on CSV best practices
• Contribute to Infiligence's validation methodology and knowledge base

What You Bring
Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field
• 5+ years of hands-on CSV experience in life sciences/pharmaceutical environments
• Deep expertise in validation lifecycle (V-Model, Agile Validation)
• Strong working knowledge of FDA 21 CFR Part 11, EU GxP, GAMP 5 (v5 categories), and Annex 11
• Experience validating systems such as: LIMS, ERP (SAP, Oracle), MES, SCADA, QMS, EDC, CTMS, or EHR/EMR platforms
• Proficiency in creating validation documentation per global standards

Preferred Qualifications

• Experience with CSV for cloud-based systems (AWS, Azure, Veeva, Salesforce)
• Familiarity with data integrity (ALCOA+) principles
• Knowledge of electronic signatures and audit trail requirements
• Exposure to automated testing tools for validation (Selenium, TestComplete)
• Prior experience supporting FDA/EMA/MHRA inspections
• Certifications: ASQ (CSQE, CQE), RAPS, or ISPE GAMP certification

Essential Skills

• Excellent technical writing and documentation skills
• Strong analytical and problem-solving abilities
• Detail-oriented with exceptional organizational skills
• Effective communication with technical and non-technical stakeholders
• Ability to work independently and manage multiple priorities
• Flexibility for occasional overlap with US/Canada time zones

Why Infiligence Chennai?
Global Impact, Local Team

• Work directly with North American life science innovators from Chennai
• Exposure to cutting-edge digital health, biotech, and pharma technologies
• Build deep domain expertise in a high-growth specialty

Career Growth

• Clear path from CSV Specialist Senior Validation Engineer Validation Lead Practice Lead
• Investment in professional certifications (ISPE, RAPS, ASQ)
• Opportunity to cross-train in DevSecOps, Cloud Validation, and Quality Engineering

Competitive Package

• Industry-leading compensation benchmarked to Chennai life sciences market
• Performance bonuses tied to project delivery and client satisfaction
• Health insurance for employee + family
• Provident Fund and Gratuity
• Paid time off and flexible working arrangements
• Professional development allowance
• ESOPs

Location & Work Model

• Office: Chennai, Tamil Nadu
• Work Mode: In-Person
• Travel: Minimal (occasional client visits if required; potential for US/Canada travel for senior roles)

Skills Required