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 new 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 given the platform’s smart capabilities.
- Experience preparing companies for vendor audits by major pharma.
Why Join Us (vs. a Big Company)??
● True Ownership – You’ll help design and build a platform from the ground up. Every feature, every decision, every improvement — you’ll be part of it.
● Mission-Driven Work – We’re solving critical problems in pharma manufacturing that improve safety, compliance, and efficiency.
● Accelerated Growth – With us, you’ll learn faster, stretch your skills, and take on challenges that would take years to access elsewhere.
● Startup Energy, Real Impact – No red tape. No silos. Just smart, motivated people building something meaningful together.
● End-to-End Visibility – Be part of the full journey — from whiteboard to deployment — and actually see how your work changes the game.
● Build category-defining products for regulated life sciences
● Work on cutting-edge AI + vector search in real-world GxP environments
● High ownership, real impact, and direct collaboration with US leadership
● Opportunity to influence platform architecture from early stages
Why You’ll Love It Here??
Here are some things you will be a part of:
● Build foundational products with real-world impact in life sciences.
● Work directly with founders and be part of early product leadership.
● Flexible remote work, async-friendly culture.
● Competitive equity, startup perks, and growth opportunities.
● Help define the culture of a product-first, purpose-driven startup.
Benefits:
- Cell phone reimbursement
- Health insurance
- Internet reimbursement
- Life insurance
- Paid sick time
- Paid time off
- Provident Fund
- Work from home
Experience:
- CSV within pharma/biotech/medical devices: 10 years (Required)
- validating cloud/SaaS and multi-tenant systems: 5 years (Required)
- GAMP 5: 5 years (Required)
- 21 CFR Part 11: 5 years (Required)
- EU Annex 11: 5 years (Required)
- preparing companies for vendor audits by major pharma: 3 years (Required)
- AI/ML system validation: 3 years (Preferred)
Work Location: Remote
