Designation ELN Validation Engineer Biovia Application Systems Qualification Bachelor s or master s 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 recent Joiners - depending on daylight saving Client Brief As a pioneering biopharmaceutical leader the 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 Strong hands-on experience in Computer System Validation CSV for ELN Electronic Laboratory Notebook Thorough understanding of GxP GAMP 5 and 21 CFR Part 11 Proven experience in authoring and executing validation protocols IQ OQ PQ Experience with documentation systems such as Veeva Vault Trackwise or similar Knowledge of change control deviation CAPA and audit trail review Strong analytical problem-solving and technical writing skills Proficient in tools like MS Office Jira and Confluence Desired Skills Exposure to other Biovia systems such as LES LIMS Pipeline Pilot Familiarity with cloud-based validation approaches e g SaaS ELN systems Knowledge of Pharmacovigilance or Regulatory Compliance workflows Experience supporting global validation projects across time zones Personal Attributes Detail-oriented with a high level of documentation accuracy Proactive and accountable with a solution-driven mindset Strong communication and stakeholder management skills Ability to work independently and in cross-functional teams Adaptable to changing priorities in a fast-paced environment Committed to quality compliance and continuous improvement Job Types Full-time Permanent Pay Up to 2 500 000 00 per year Experience Computer System Validation CSV lifecycle 3 years Required validating Biovia ELN in a GxP-regulated environment 3 years Required Shift availability Night Shift Required Overnight Shift Preferred Work Location Remote

📌 Eln Validation (csv) Engineer (biovia Applications / System) - Biopharma / Lifescience
🏢 ITSoli India
📍 India