Senior Computer System Validation (CSV) / CSA Lead

Aligned Automation, LLC; Pune District; On-site; INR 1,500,000 - 2,000,000; Full time

Job summary

Aligned Automation, LLC in Pune District is seeking a Senior Computer System Validation (CSV) / CSA Lead to manage validation and compliance within GxP-regulated systems. The successful candidate will lead end-to-end CSV/CSA lifecycle activities, ensuring compliance with crucial regulations such as FDA 21 CFR Part 11 and EU Annex 11.

With over 8 years of experience in CSV/CSA within regulated environments, you will develop risk-based validation strategies and manage technical leadership across projects.

Qualifications

• 8+ years of experience in CSV/CSA within pharmaceutical, biotech, or regulated manufacturing environments.
• Experience validating enterprise, manufacturing, laboratory, automation, cloud, and infrastructure systems.
• Strong expertise in FDA 21 CFR Part 11, EU Annex 11, GAMP 5, CSA, and Data Integrity regulations.

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.
• Execute and oversee qualification activities including IQ, OQ, PQ.

Skills

Computer System Validation (CSV)

Computer Software Assurance (CSA)

Software Validation

Data Integrity

GxP Compliance

IQ/OQ/PQ

Education

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline

Job description

Aligned Automation Services Pvt Ltd | Full time

Senior Computer System Validation (CSV) / CSA Lead

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 our4Cs—Care,Courage,Curiosity, andCollaboration—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 environment.

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 Systems
  • MES,LIMS,SCADA,ERP,QMS
  • Historian Systems
  • Laboratory Instruments
  • Chromatography Systems
• Ensure compliance with:
  • FDA 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • CSA Guidance
  • Data Integrity and ALCOA+ requirements
• Manage change controls, deviations, CAPAs, incidents, periodic reviews, and validation impact assessments.
• Support regulatory inspections, audits, and remediation activities.
• Collaborate with QA, IT, Engineering, Automation, Manufacturing, and external vendors.
• Mentor junior validation engineers and provide technical leadership across projects.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline.
• 8+ years of experience in CSV/CSA within pharmaceutical, biotech, or regulated manufacturing environments.
• Strong expertise in:
  • Computer System Validation (CSV)
  • Computer Software Assurance (CSA)
  • Software Validation
  • IQ/OQ/PQ
  • Data Integrity
  • GxP Compliance
  • SDLC Validation
• Experience validating enterprise, manufacturing, laboratory, automation, cloud, and infrastructure systems.
• Strong working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, CSA, and Data Integrity regulations.