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 looking for an experienced Computer System Validation (CSV) / Computer Software Assurance (CSA) Engineer to support validation and compliance activities for GxP-regulated computerized systems within the pharmaceutical and life sciences industry.

The ideal candidate will have hands-on experience in validating custom-built applications, enterprise systems, cloud/SaaS solutions, manufacturing, laboratory, and automation systems. The role requires solid knowledge of CSV, CSA,



Software Validation, Data Integrity, and qualification activities (IQ/OQ/PQ), ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ principles.

Key Responsibilities
- Execute end-to-end CSV and CSA activities across the computerized system lifecycle.
- Develop and execute risk-based validation strategies in accordance with GAMP 5 and FDA CSA guidance.
- Author, review, and maintain validation documentation, including:
- Validation Plans
- User, Functional, and Design Specifications (URS/FS/DS)
- Risk Assessments
- Traceability Matrices
- IQ/OQ/PQ, FAT, and SAT protocols
- Validation Summary Reports
- SOPs and Work Instructions
- Perform validation of GxP-regulated systems, including:
- Custom-built web and enterprise applications
- Software developed using low-code/no-code platforms (e.g., Microsoft Power Platform, Mendix, OutSystems)
- SaaS and cloud-based applications

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