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 strong 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
- Manufacturing Execution Systems (MES)
- ERP and Quality Management Systems (QMS)
- Historian systems
- Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
- Perform validation impact assessments for system changes, upgrades, patches, and infrastructure changes.
- Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, CSA guidance, ALCOA+, and Data Integrity requirements.
- Support change controls, deviations, CAPAs, incident investigations, and periodic reviews.
- Participate in internal and external audits and support regulatory inspections.
- Collaborate with QA, IT, Engineering, Automation, Manufacturing, vendors, and business stakeholders throughout the system lifecycle.
Required Qualifications
- Bachelor's degree in Computer Science, Engineering, Information Technology, Life Sciences, or a related discipline.
- 5+ years of experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA) within pharmaceutical, biotechnology, medical device, or other regulated environments.
- Hands-on experience validating custom-built web applications and high-risk GxP-regulated applications.
- Experience validating enterprise, manufacturing, laboratory, cloud, automation, and infrastructure systems.
- Strong understanding of Software Development Lifecycle (SDLC) and application validation methodologies.
- Practical experience with:
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- Software Validation
- IQ/OQ/PQ
- Risk Assessments
- Traceability Matrix development
- Data Integrity (ALCOA+)
- GxP Compliance
- Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and current FDA CSA guidance.
Preferred Qualifications
- Experience validating applications built on Microsoft Power Platform, Salesforce, ServiceNow, Mendix, OutSystems, or similar low-code platforms.
- Experience validating cloud-native and SaaS applications.
- Familiarity with REST APIs, system integrations, databases, and web technologies used in modern application architectures.
- Experience supporting FDA, EMA, MHRA, or other regulatory inspections.
- Knowledge of Agile/DevOps validation and automated testing practices is an advantage.
