Website:
eclipticinsight.com
Job details:
Computer System Validation (CSV) & Quality Specialist
Job Title: Computer System Validation (CSV) & Quality Specialist
Employment Type: Full-time ( Contract )
Location: Remote
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The Role
We build AI that helps pharma and life sciences manufacturers capture expert knowledge, guide operators through standard work, and verify execution in real time — all within a GMP-compliant, audit-ready platform.
As our first Validation & Quality hire, you'll make sure that platform holds up when a pharma customer's QA team walks in the door. That means owning CSV and QA end-to-end — writing the validation protocols, standing up the quality system from scratch, and pushing back on engineering when something won't pass muster under 21 CFR Part 11 or EU Annex 11.
This is a build-and-ship role. If you've validated regulated SaaS before, know GxP inside out, and want to be the person who makes AI in pharma actually audit-ready — read on.
What You'll Do
• Author and execute IQ, OQ, and PQ protocols for our cloud-based AI platform
• Write and maintain the Validation Master Plan, SOPs, and traceability matrix
• Define test strategies and write test scripts tied to User Requirements Specs (URS)
• Perform gap assessments against 21 CFR Part 11 and EU Annex 11
• Review software change controls for validation and QA impact
• Push back on engineering when a change would fail an audit — and document it
• Serve as the primary validation contact during pharma customer audits
• Manage audit trail reviews and periodic system reviews
• Support CAPA and deviation processes as needed
What You Must Have
• 7+ years of CSV experience, with at least 3 years in SaaS or cloud-hosted systems
• Independently authored IQ/OQ/PQ protocols — not co-authored, not reviewed
• Direct experience supporting or leading an external pharma or FDA audit
• A track record of raising compliance issues with engineering and holding the line
• Strong working knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5
• Able to write and execute test scripts linked to requirements
• Clear communicator — you can explain compliance to non-QA stakeholders
• Self-directed: comfortable building from scratch without existing infrastructure
Nice to Have
• Experience adapting CSV for Agile or DevOps continuous delivery environments
• Test automation skills (Selenium, Playwright, or similar)
• Background in LIMS, MES, eTMF, or other clinical or lab informatics systems
• Familiarity with ALCOA+ data integrity principles
• ASQ CQA or equivalent quality certification
This Role Is Not for You If…
• Your validation experience is limited to on-premise or paper-based systems
• You've never been in an audit room without a consultant or senior QA present
• You see validation primarily as a documentation exercise
• You expect a separate regulatory team to make compliance calls
- • You need more than two weeks before producing your first deliverable
Click on Apply to know more.
