Senior System Engineer (51135)

Company Overview

Incedo is a US-based consulting, data science and technology services firm with over 3000 people helping clients

from our six offices across US, Mexico and India. We help our clients achieve competitive advantage through

end-to-end digital transformation. Our uniqueness lies in bringing together strong engineering, data science, and

design capabilities coupled with deep domain understanding. We combine services and products to maximize

business impact for our clients in telecom, Banking, Wealth Management, product engineering and life science

& healthcare industries.

Working at Incedo will provide you an opportunity to work with industry leading client organizations, deep

technology and domain experts, and global teams. Incedo University, our learning platform, provides ample

learning opportunities starting with a structured onboarding program and carrying throughout various stages of

your career. A variety of fun activities is also an integral part of our friendly work environment. Our flexible

career paths allow you to grow into a program manager, a technical architect or a domain expert based on your

skills and interests.

Our Mission is to enable our clients to maximize business impact from technology by

• Harnessing the transformational impact of emerging technologies
• Bridging the gap between business and technology

Role Description

Job Summary

We are looking for an experienced Computer System Validation (CSV) Engineer to support the validation of computerized systems used in pharmaceutical, biotechnology, and other regulated environments. The ideal candidate will have strong expertise in GxP compliance, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, validation documentation, and system testing. Experience with laboratory systems, quality management systems, and electronic laboratory notebooks is highly desirable.

Key Responsibilities

• Develop and execute CSV documentation, including Validation Plans, User Requirements Specifications (URS), Functional and Design Specifications, Risk Assessments, Test Scripts, RTMs, and Validation Summary Reports.
• Perform and support Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), System Integration Testing (SIT), and User Acceptance Testing (UAT).
• Ensure computerized systems comply with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable GxP regulations.
• Validate and maintain laboratory and quality systems, including ELN, LIMS, QMS, and other regulated applications.
• Support system implementation, upgrades, configuration changes, integrations, data migration, and periodic reviews.
• Manage deviations, defects, change controls, CAPAs, and validation-related investigations.
• Conduct data integrity assessments and verify electronic records, electronic signatures, audit trails, and access controls.
• Collaborate with Quality Assurance, IT, laboratory operations, business stakeholders, and vendors.
• Maintain validation documentation, SOPs, traceability records, and audit-ready evidence.
• Use tools such as ValGenesis, Veeva Vault, Jira, HP ALM, and automated testing tools to support validation activities.

Technical Skills

Nice-to-have skills

Qualifications

Required Qualifications

• Bachelors degree in Computer Science, Information Technology, Engineering, or a related field.
• 8+ years of experience in Computer System Validation within pharmaceutical, biotechnology, or other GMP-regulated environments.
• Strong knowledge of GxP, FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Hands-on experience preparing and executing validation protocols and documentation.
• Experience with IQ/OQ/PQ, UAT, SIT, requirements traceability, and defect management.
• Understanding of data integrity, electronic records, electronic signatures, and audit trails.
• Experience with change control, deviations, CAPA, and risk-based validation.
• Strong documentation, communication, troubleshooting, and stakeholder-management skills.

Preferred Qualifications

• Experience with BIOVIA ELN, LIMS, Veeva Vault QualityDocs, or ValGenesis.
• Experience validating system integrations and performing data migration and reconciliation.
• Knowledge of SQL for database validation and data verification.
• Experience with automated testing tools such as UFT and test management tools such as HP ALM or Jira.
• Experience supporting multi-site GxP system implementations and regulatory audits.

Company Value

We value diversity at Incedo. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.