Designation : Discoverant Computer System Validation (CSV) Engineer

Qualification : Bachelors or masters degree in computer science, Information Technology, Life Sciences, Pharmacy or a related discipline

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.

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