About Us
We are a US-based startup building next-generation software platforms for regulated life sciences manufacturing and laboratories.Our products operate in GxP-regulated environments, requiring strong engineering discipline, validation readiness, and security-by-design.
Here, you won’t just be a cog in the machine — you’ll be part of building the machine. If you thrive in environments where you can wear multiple hats, roll up your sleeves, and see your work through from start to finish, this is your opportunity to make a real impact.
We’re creating a culture of builders, thinkers, and problem-solvers who aren’t afraid to challenge the status quo. Your voice will be heard, your ideas will matter, and your contributions will shape the future of our product and the industry.
WHAT YOU WILL DO
We seek an experienced CSV Lead to validate the GMP execution platform and prepare the company for vendor audits by pharmaceutical customers.
SCOPE OF WORK
- Gap assessment against 21 CFR Part 11, EU Annex 11, and GAMP 5 Category 4/5 requirements.
- SDLC documentation: change control,
code review, regression testing, release management, and requirements traceability.
- Review and validate the IQ/OQ/PQ templates created by the internal GMP Specialist.
- Validate the application Engine’s data protection architecture — confirm tenant isolation, data purging, and zero-retention guarantees meet regulatory expectations.
- Vendor audit readiness package: system description, infrastructure qualification, security documentation, Supplier Quality Agreement.
- Ongoing validation strategy for current feature releases including risk-based change impact assessment.
REQUIRED SKILLS
- 10+ years in computer system validation within pharma/biotech/medical devices.
- Proven track record validating cloud/SaaS and multi-tenant systems.
- Deep expertise in GAMP 5 (including 2022 second edition), 21 CFR Part 11, EU Annex 11.
- Experience with AI/ML system validation is a significant advantage gi
📌 Computer System Validation (India)
🏢 Bhrigu
📍 India