ITSoli - GxP Computer System Validation Engineer

Qualification : Bachelor's Degree in Computer Science, Information Technology, Biotechnology, Life Sciences, Pharmaceutical Sciences, Bioinformatics, Engineering or a related discipline. Equivalent combination of education and relevant industry experience may be considered.

Job Role :

The GxP Validation Engineer will be responsible for planning, executing and maintaining Computer System Validation (CSV) activities for regulated Scientific Informatics and Laboratory Systems used across Research, Quality Control, Manufacturing and Clinical environments. The role will ensure compliance with global regulatory requirements, support validation lifecycle activities and maintain audit readiness of regulated systems throughout their lifecycle. The engineer will collaborate closely with Quality Assurance, Laboratory Operations, Manufacturing, IT, Business Stakeholders and Vendors to support implementation, upgrades, integrations and continuous compliance initiatives.

Key Responsibilities : A) Computer System Validation :

• Execute end-to-end Computer System Validation (CSV) activities for regulated laboratory and scientific applications.

• Develop, review and maintain validation documentation including :

• Validation Plans

• User Requirements Specifications (URS)

• Functional Specifications

• Risk Assessments

• IQ, OQ and PQ Protocols

• Traceability Matrix (RTM)

• Validation Summary Reports

• Develop and execute validation test scripts and document test evidence.

B) Compliance & Regulatory Support :

• Ensure compliance with :

• FDA 21 CFR Part 11

• EU Annex 11

• GAMP 5

• Data Integrity (ALCOA+)

• Internal Quality and Compliance Standards

• Maintain audit-ready documentation and support regulatory inspections and compliance audits.

• Participate in periodic reviews and revalidation activities.

C) Change Control & Lifecycle Management :

• Perform impact assessments for system upgrades, patches, enhancements and configuration changes.

• Support Change Control, CAPA, Deviation Management and validation lifecycle processes.

• Participate in implementation, migration, upgrade and retirement activities for validated systems.

D) Cross-Functional Collaboration :

• Work closely with :

• Quality Assurance

• IT Teams

• Laboratory Operations

• Manufacturing Teams

• Business Stakeholders

• External Vendors

• Provide validation guidance and compliance support throughout project lifecycles.

Required Skills : A) Validation & Compliance :

• Strong hands-on experience in Computer System Validation (CSV) within GxP-regulated environments.

• Experience preparing and executing validation deliverables including :

• URS

• Risk Assessments

• IQ/OQ/PQ

• RTM

• Validation Plans

• Validation Reports

• Thorough understanding of :

• FDA 21 CFR Part 11

• EU Annex 11

• GAMP 5

• Data Integrity (ALCOA+)

• Experience supporting regulatory inspections and compliance audits.

B) Scientific Informatics Systems :

• Hands-on validation experience with following systems :

• Scientific Data Management Systems (SDMS)

• Electronic Laboratory Notebooks (ELN)

• Waters Empower CDS

• LabX

• SoftMax Pro

• Laboratory Information Management Systems (LIMS)

• Experience with BIOVIA Discoverant is highly preferred.

C) Validation Lifecycle Management :

• Change Control Management

• CAPA Management

• Deviation Handling

• Risk-Based Validation Approaches

• Periodic Reviews

• Revalidation Activities

D) Technical Skills :

• Understanding of Software Development Lifecycle (SDLC)

• Validation lifecycle methodologies

• Electronic Records and Electronic Signatures

• Audit Trail Reviews

• Data Integrity Controls

• Validation and test management tools such as Jira, HP ALM, Azure DevOps or similar platforms

Desired Skills :

• Experience validating cloud-based or SaaS applications.

• Knowledge of laboratory instrument integrations and data acquisition systems.

• Familiarity with Pharmaceutical R&D, Quality Control, Manufacturing and GMP processes.

• Experience supporting system upgrades, migrations and implementation projects.

• Exposure to scientific informatics ecosystems and laboratory automation platforms.

Personal Attributes :

• Strong commitment to quality, compliance and documentation excellence.

• Excellent analytical and problem-solving skills.

• Ability to work independently in highly regulated environments.

• Strong written and verbal communication skills.

• Effective stakeholder management and collaboration abilities.

• Self-motivated organized and capable of managing multiple priorities simultaneously.