ITSoli - ELN Computer System Validation Engineer

Description : ELN Computer System Validation (CSV) Engineer

Qualification : Bachelors or masters degree in Life Sciences, Computer Science, Information Technology or a related discipline.

Experience :

- Minimum 3+ years of hands-on CSV experience in GxP Life Sciences environments, with expertise in ELN systems (Biovia preferred), validation lifecycle (URS to VSR) and regulatory compliance (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).

Work Timing :

Work schedule can be split into 4 hours PM (IST) and 4 hours AM (PST) working hours once KT (Knowledge Transfer) days are completed for new Joiners During KT Period (i.e. 3 months) work schedule will be complete US (PST) working hours.

Client Brief :

A pioneering biopharmaceutical leader, our organization is driven by a mission to discover, develop and deliver transformative therapies that improve the lives of people around the world. With a deep focus on innovation, we have introduced ground-breaking treatments across areas such as virology, oncology and inflammation. Our trailblazing work has contributed to global advancements in HIV treatment and the fight against viral diseases. Recognized for a robust pipeline and a legacy of scientific excellence, we continuously invest in cutting-edge research and strategic partnerships. Our commitment to access, sustainability and patient-centric innovation has earned us accolades as one of the most admired and socially responsible companies in the healthcare industry.

Job Role :

We are seeking a skilled ELN CSV Engineer to support validation activities for Electronic Laboratory Notebook systems in regulated Life Sciences environments. The role involves ensuring compliance with global regulatory standards while managing validation lifecycle activities for ELN platforms, with a strong preference for experience in BIOVIA-based applications. The candidate will collaborate with cross-functional teams including IT, Quality and Business stakeholders to ensure validated, compliant and audit-ready systems.

Key Responsibilities :

- Execute end-to-end CSV lifecycle activities for ELN systems (planning, execution and reporting)

- Develop and review validation deliverables including Validation Plans, URS, FS/DS, Risk Assessments, IQ/OQ/PQ protocols and Summary Reports

- Ensure compliance with regulatory standards such as FDA 21 CFR Part 11, EU Annex 11 and GAMP 5 guidelines

- Perform impact assessments, change control evaluations and periodic reviews

- Support audit readiness and participate in internal/external audits and inspections

- Collaborate with IT, Quality Assurance and business stakeholders to gather and define system requirements

- Ensure data integrity, system security and compliance with ALCOA+ principles

- Support incident management, deviation handling and CAPA processes

- Work closely with ELN platform teams for system enhancements, upgrades and integrations

Required Skills :

- Strong hands-on experience in Computer System Validation (CSV) in GxP environments

- Experience with Electronic Laboratory Notebook (ELN) systems (BIOVIA preferred)

- In-depth knowledge of validation lifecycle documentation (VMP, URS, FS/DS, IQ/OQ/PQ)

- Good understanding of regulatory compliance : FDA 21 CFR Part 11, EU Annex 11, GAMP 5

- Experience in risk-based validation approaches and data integrity principles (ALCOA+)

- Familiarity with change control, deviation management and CAPA processes

- Strong documentation, review and stakeholder communication skills

Desired Skills :

- Experience with BIOVIA ELN or related laboratory informatics platforms

- Exposure to LIMS, SDMS or other Lab Informatics systems

- Knowledge of cloud-based validation and SaaS platforms

- Basic understanding of scripting or system configuration (e.g., Python, .NET)

- Experience with Agile/DevOps environments in validated systems

Personal Attributes :

- Strong analytical and problem-solving mindset

- Detail-oriented with a focus on quality and compliance

- Excellent communication and stakeholder management skills

- Ability to work independently and in cross-functional teams

- Proactive, adaptable and audit-ready approach