Senior Computer System Validation (CSV) / CSA Lead

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 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.