Designation: Discoverant Computer System Validation (CSV) Engineer
Qualification: Bachelor’s or master’s degree in computer science, Information Technology, Life Sciences, Pharmacy or a related discipline
Experience: Minimum 3+ years of hands-on experience in Computer System Validation (CSV) within GxP-regulated Life Sciences environments, with expertise in validating Discoverantor similar data-centric applications, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11 and GAMP 5 and exposure to BIOVIA-based systems preferred.
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: 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: We are seeking a skilled Discoverant CSV Engineer to support validation and compliance activities for regulated systems within a Life Sciences environment. The role involves executing end-to-end Computer System Validation (CSV) lifecycle activities for Discoverant and associated applications, ensuring adherence to global regulatory standards. The ideal candidate will have hands-on experience in GxP systems, strong documentation capabilities and familiarity with Biovia-based applications or similar scientific platforms.
Key Responsibilities:
- Execute and manage CSV lifecycle activities including Validation Plans, URS, FS/DS, IQ, OQ, PQ and Validation Summary Reports
- Perform risk assessments and ensure compliance with GAMP 5 guidelines and regulatory requirements
- Validate Discoverant systems and ensure data integrity, audit trails and system security controls are compliant
- Collaborate with cross-functional teams including IT, Quality Assurance and Business stakeholders
- Support system upgrades, patches and change control processes in validated environments
- Review and approve validation documentation and ensure audit readiness
- Participate in internal and external audits, addressing validation-related observations
- Ensure adherence to data integrity principles (ALCOA+) and regulatory expectations
- Maintain validation traceability and documentation repositories
Required Skills:
- Strong hands-on experience in Computer System Validation (CSV) within GxP-regulated environments
- Experience with Discoverant or similar data analytics / scientific data systems
- Thorough understanding of FDA 21 CFR Part 11, EU Annex 11 and GAMP 5
- Expertise in validation documentation (URS, FS/DS, IQ/OQ/PQ, RTM, VSR)
- Experience in change control, deviation management and CAPA processes
- Knowledge of data integrity and compliance requirements
- Strong stakeholder communication and documentation skills
Desired Skills:
- Experience with BIOVIA applications/systems (e.g., ELN, Pipeline Pilot or related platforms)
- Familiarity with Laboratory Systems, LIMS or Scientific Data Management Systems (SDMS)
- Basic understanding of SQL, scripting or system integrations
- Exposure to cloud-based validation environments or SaaS platforms
Personal Attributes:
- Strong attention to detail and quality-oriented mindset
- Excellent analytical and problem-solving skills
- Ability to work collaboratively in cross-functional teams
- Proactive, self-driven and adaptable to dynamic environments
- Strong organizational and time management skills
- Effective communication and stakeholder management abilities
Job Types: Full-time, Permanent
Pay: Up to ₹2,500,000.00 per year
Experience:
- end-to-end CSV lifecycle activities (URS, IQ, OQ, PQ, VSR): 2 years (Required)
- BIOVIA applications/systems (ELN, Pipeline Pilot, etc.): 1 year (Preferred)
- CSV within GxP-regulated environments: 3 years (Required)
- Discoverant or similar scientific/data analytics systems: 2 years (Required)
Shift availability:
- Night Shift (Required)
- Overnight Shift (Preferred)
Work Location: Remote
