ITSoli - Biovia ELN Validation Engineer

Designation : ELN Validation Engineer - Biovia (application / systems)

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

Experience : Minimum 3+ years of hands-on experience in CSV / Validation of Electronic Laboratory Notebook (ELN) systems , in a GxP-compliant pharmaceutical / biotech environment

Work Timing : US ( PST ) Hours (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 - depending on daylight saving)

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 groundbreaking 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 :

As an ELN Validation Engineer , you will be responsible for Computer System Validation (CSV) of Electronic Laboratory Notebook (ELN) systems. The role involves planning, executing, and documenting validation activities in compliance with regulatory standards including GAMP 5, 21 CFR Part 11, and GxP requirements. You will closely collaborate with IT, Quality Assurance, Laboratory, and Regulatory teams to ensure that ELN systems are validated, maintained, and operated within a validated state across their lifecycle.

Key Responsibilities :

• Lead and execute Computer System Validation (CSV) for Biovia ELN systems.
• Author validation documentation including Validation Plan, URS, Risk Assessments, IQ / OQ / PQ Protocols, and Validation Summary Reports.
• Ensure compliance with GxP, 21 CFR Part 11, GAMP 5, and company validation policies.
• Participate in requirement gathering, gap assessments, and impact assessments for ELN systems.
• Manage change controls and periodic reviews for validated systems.
• Collaborate with cross-functional teams : IT, QA, business users, and external vendors to support validation efforts.
• Support internal and external audits and inspections with validation documentation and readiness.
• Monitor system performance post-deployment and ensure it remains in a validated state.
• Contribute to SOP development and continuous improvement of validation practices.

Required Skills :

Desired Skills :

Personal Attributes :

(ref : hirist.tech)