Discoverant Validation (CSV) Engineer - Biovia (BioPharma / Lifescience) Technology Domain
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Designation: Discoverant Validation (CSV) Engineer (Biovia Application / Systems)
Qualification: Bachelor’s or Master’s degree in Computer Science, Life Sciences, Bioinformatics, Biotechnology, Engineering, or related discipline.
Experience: Minimum 3+ years hands-on experience in Computer System Validation (CSV) of Biovia Discoverant or equivalent pharma analytics platforms, including experience with GxP systems.
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: 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: The Discoverant Validation Engineer will play a crucial role in ensuring that Biovia Discoverant implementations and enhancements at Gilead Sciences meet regulatory compliance and validation standards. This position will focus on Computer System Validation (CSV), documentation, risk assessment, testing, and quality assurance of Discoverant and related Biovia applications. The engineer will closely collaborate with Quality, IT, Business, and Validation teams to deliver validated, audit-ready systems for regulated manufacturing and quality environments.
Key Responsibilities:
- Lead and execute Computer System Validation (CSV) activities for Biovia Discoverant and integrated systems
- Develop and maintain validation documentation (URS, FS, DS, Risk Assessments, IQ, OQ, PQ, Traceability Matrix, Validation Plan/Report)
- Ensure validation strategies align with GAMP 5 guidelines, 21 CFR Part 11, and Annex 11
- Collaborate with cross-functional teams (IT, QA, Business, Vendors) for validation planning and execution
- Support audits and inspections by providing validation evidence and documentation
- Perform impact assessments for system changes and revalidation requirements
- Maintain audit trail and configuration control in a compliant manner
- Support testing efforts including writing test scripts and managing deviations
- Provide training and knowledge transfer on validated systems to business and IT users
Required Skills:
- Strong experience in validating Biovia Discoverant in a GxP-regulated environment
- In-depth knowledge of Computer System Validation (CSV) lifecycle
- Familiarity with GAMP 5, 21 CFR Part 11, EU Annex 11 compliance frameworks
- Excellent documentation skills (URS, IQ/OQ/PQ, Validation Plans/Reports)
- Understanding of manufacturing and quality processes in the pharmaceutical industry
- Hands-on experience in managing validation activities through tools like HP ALM, Veeva Vault QMS, or similar platforms
- Strong analytical and problem-solving skills
Desired Skills:
- Knowledge of other Biovia platforms such as Biovia Pipeline Pilot, LIMS, ELN
- Exposure to integration scenarios between Discoverant and systems like LIMS, MES, ERP, SCADA
- Familiarity with data integrity principles (ALCOA+)
- Experience with risk-based validation approaches
- Agile/SDLC methodology understanding in a regulated context
Personal Attributes:
- Detail-oriented and methodical approach to validation
- Excellent communication and documentation skills
- Collaborative team player with ability to engage multiple stakeholders
- Strong time-management and multi-tasking abilities
- Ability to work independently with minimal supervision
- Quality and compliance mindset
- Proactive attitude in identifying validation risks and proposing mitigations
Job Types: Full-time, Permanent
Pay: Up to ₹3,000,000.00 per year
Experience:
- Computer System Validation (CSV) lifecycle: 3 years (Required)
- validating Biovia Discoverant in a GxP-regulated environment: 2 years (Required)
Shift availability:
- Night Shift (Required)
- Overnight Shift (Preferred)
Work Location: Remote
