Designation: GxP Validation Engineer - Biovia (ELN / Discoverant)
Qualification: Bachelor's Degree in Computer Science, Information Technology, Biotechnology, Life Sciences, Bioinformatics, Pharmaceutical Sciences, Engineering, or a related discipline. Equivalent combination of education and relevant industry experience may be considered.
Certifications: (Preferred)
- GAMP 5 Foundation or Advanced Certification
- Certified Computer System Validation (CSV) Certification
- ITIL Foundation
- Regulatory Compliance Training (21 CFR Part 11, EU Annex 11)
- BIOVIA Platform Administration or Functional Training
Experience: Minimum 3+ Years of hands-on experience in GxP Computer System Validation (CSV) including 2+ Years of experience supporting or validating Biovia ELN (and/or) Biovia Discoverant, or similar regulated laboratory/manufacturing systems.
Work Location: Remote (India) - Working in collaboration with US Service Delivery Team, supporting US Biopharmaceutical clients.
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 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 GxP Validation Engineer will be responsible for validating and maintaining compliance of regulated computerized systems, with a primary focus on BIOVIA ELN and/or BIOVIA Discoverant platforms. The role will support implementation, enhancement, integration, and lifecycle management activities while ensuring adherence to GxP requirements, FDA regulations, data integrity standards, and industry best practices. The engineer will work closely with Quality Assurance, IT, Business Stakeholders, Validation Teams, and Vendors to ensure systems remain audit-ready, validated, and compliant throughout their lifecycle.
Key Responsibilities:
- Execute end-to-end Computer System Validation (CSV) activities for BIOVIA ELN and/or BIOVIA Discoverant systems.
- Author, review, and maintain validation documents including URS, Risk Assessments, IQ, OQ, PQ, RTM, and Validation Reports.
- Ensure compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 requirements.
- Perform impact assessments and validation activities for system changes, upgrades, and enhancements.
- Develop, execute, and document validation test scripts and test evidence.
- Support deviation management, CAPA implementation, and change control processes.
- Collaborate with Quality, IT, Business, and Vendor teams throughout the system validation lifecycle.
- Maintain audit-ready validation documentation and support regulatory inspections and compliance audits.
- Verify data integrity, electronic records, electronic signatures, and audit trail compliance requirements.
- Participate in periodic reviews, revalidation activities, and continuous compliance improvement initiatives.
Required Skills:
- Strong hands-on experience in Computer System Validation (CSV) within GxP-regulated pharmaceutical or life sciences environments.
- Proven experience validating and supporting BIOVIA ELN and/or BIOVIA Discoverant applications.
- In-depth knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and Data Integrity (ALCOA+) requirements.
- Expertise in preparing and executing validation deliverables including URS, IQ, OQ, PQ, RTM, Risk Assessments, and Validation Reports.
- Experience managing Change Controls, Deviations, CAPAs, and validation lifecycle activities.
- Strong understanding of SDLC methodologies and risk-based validation approaches for regulated systems.
- Excellent documentation, analytical, troubleshooting, and stakeholder communication skills.
Desired Skills:
- Experience with additional regulated systems such as LIMS, SDMS, QMS, MES, or other Scientific Informatics platforms.
- Knowledge of system integrations involving BIOVIA ELN/Discoverant, laboratory applications, and enterprise systems.
- Exposure to SaaS/cloud-based validation and computerized system compliance frameworks.
- Familiarity with validation and test management tools such as HP ALM, Veeva Vault, Jira, or Azure DevOps.
- Understanding of pharmaceutical R&D, Quality Control, Manufacturing, or GMP business processes.
Personal Attributes:
- Detail-oriented professional with a strong commitment to quality, compliance, and documentation accuracy.
- Analytical problem-solver capable of assessing risks and resolving validation-related issues effectively.
- Excellent communicator with the ability to collaborate across global cross-functional teams and stakeholders.
- Self-driven and accountable individual with strong organizational and time management skills in a regulated environment.
Pay: Up to ₹2,500,000.00 per year
Benefits:
- Flexible schedule
- Provident Fund
- Work from home
Experience:
- Computer System Validation (CSV) within GxP environment: 3 years (Required)
- BIOVIA (ELN and/or Discoverant) validation: 2 years (Required)
Shift availability:
- Night Shift (Preferred)
- Overnight Shift (Required)
Work Location: Remote
