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
- 7+ 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
- Solid 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

📌 Senior Validation and Verification Specialist (Tamil Nadu)
🏢 Infiligence
📍 Tamil Nadu