Electronic Laboratory Notebook ELN System Administrator - ITSoli India Pvt Ltd.

Designation: Electronic Laboratory Notebook (ELN) System Administrator

Qualification: Bachelor’s or Master’s degree in Computer Science, Information Technology, Life Sciences, or a related field.

Experience: Minimum 3+ years of hands-on administration and support of ELN platforms within GxP-regulated Life Sciences environments , covering system configuration, user management, validation (CSV), compliance and integration with laboratory systems.

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, the client 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, they have introduced ground-breaking treatments across areas such as virology, oncology and inflammation. Their 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, they continuously invest in cutting-edge research and strategic partnerships. Their commitment to access, sustainability and patient-centric innovation has earned them accolades as one of the most admired and socially responsible companies in the healthcare industry.

Job Role: The ELN System Administrator will be responsible for the administration, maintenance and continuous improvement of Electronic Laboratory Notebook (ELN) platforms in a regulated environment. The role involves ensuring system availability, data integrity, user support and compliance with GxP standards. The individual will collaborate with cross-functional teams including R&D, Quality, IT and Validation teams to support scientific workflows and digital transformation initiatives.

Key Responsibilities:

• Administer and support ELN systems, including user management, configuration and access control
• Ensure system compliance with regulatory requirements such as GxP, 21 CFR Part 11 and Annex 11
• Perform system monitoring, performance tuning and troubleshooting
• Support system validation activities including IQ/OQ/PQ documentation and execution
• Manage system upgrades, patches and releases in coordination with vendors and internal teams
• Provide L2/L3 support for ELN-related incidents, service requests and problem management
• Collaborate with business stakeholders to gather requirements and implement enhancements
• Maintain system documentation, SOPs and audit readiness
• Support data integrity, backup and disaster recovery processes
• Participate in periodic audits and ensure compliance with internal and external standards

Required Skills: