About the Job

About Aligned Automation

At Aligned Automation, we live by our "Better Together" philosophy to build a better world. As a strategic service provider to Fortune 500 companies, we help digitize enterprise operations and drive impactful business strategies. Our purpose goes beyond projects—we strive to deliver meaningful, sustainable change that shapes a more optimistic and equitable future.

Our culture is deeply rooted in our 4Cs—Care, Courage, Curiosity, and Collaboration—ensuring that each employee is empowered to grow, innovate, and thrive in an inclusive workplace.

Role Overview

We are seeking an experienced Senior CSV / CSA Lead to manage validation, compliance, and lifecycle governance of GxP-regulated computerized systems within a pharmaceutical manufacturing setting.

The role requires deep expertise in Computer System Validation (CSV), Computer Software Assurance (CSA), Software Validation, Data Integrity, and end-to-end qualification activities including IQ/OQ/PQ. The successful candidate will lead validation activities across manufacturing, laboratory,



automation, infrastructure, cloud, and enterprise applications while ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, CSA guidance, and ALCOA+ principles.

Key Responsibilities
- Lead end-to-end CSV and CSA lifecycle activities for GxP computerized systems.
- Develop risk-based validation and assurance strategies aligned with CSA and GAMP 5 methodologies.
- Author, review, and approve:
- Validation Plans
- URS / FS / DS documents
- Risk Assessments
- Traceability Matrices
- IQ/OQ/PQ Protocols
- Validation Summary Reports
- SOPs and Work Instructions
- Execute and oversee qualification activities including IQ, OQ, PQ, FAT, SAT, and commissioning support.
- Validate all categories of GxP applications including:
- Custom built Applications
- SaaS / Cloud Applications
- Infrastructure and Server Validation
- Automated Manufacturing Systems
- Serialization and Packaging Syst

📌 Senior Computer System Validation (Pune)
🏢 Aligned Automation Services
📍 Pune