I deliver GxP-validated applications in biotech manufacturing. Most recently at Genentech, where I took a Tulip manufacturing app from a single-site pilot to a multi-building rollout, handling requirements, validation documentation, change control, and end-user training under 21 CFR Part 11.
Lead developer for Tulip Platform interfaces in a GxP-regulated environment, mentoring team members and setting development standards under 21 CFR Part 11.
Took the Tulip eCleaning App from a single-site pilot to 8 buildings across three release waves, digitizing GMP cleaning documentation and replacing paper forms. Gathered URS from stakeholder groups, wrote specs for developers, handled Go-Live and Hypercare, and trained end users.
Change Owner on releases including the Wave 2 launch and the Tulip LTS Platform Upgrade. Wrote GxP validation documentation, executed test scripts in ValGenesis, and managed change records in Veeva Vault with SMEs from other teams, with no audit findings.
Advised the Roche Singapore Tech Ops team in weekly meetings and ran a live knowledge-transfer session with the IT/OT Site Head at Roche Kaiseraugst in Switzerland.
Ran Scrum for the team (standups, sprint planning, demos, retrospectives) while also working as a developer and business analyst on that team.
Administered Salesforce CRM tracking GxP-compliant manufacturing devices and user access, supporting validation workflows and audit-ready data governance.
TulipValGenesisVeeva VaultSalesforce21 CFR Part 11
Technical Analyst at IndeedContract
Remote · Apr 2024 – Nov 2024
Owned technical onboarding for new partner integrations on Indeed APIs, serving as sole point of contact from kickoff through production launch.
Managed concurrent partner deployments in Salesforce CRM and deployed REST API integrations for data exchange, resolving escalations with Product, Engineering, Sales, and Client Services.
REST APIsSalesforcePartner Integrations
Technical Business Analyst at Gap Inc.Contract
San Francisco, CA · Sep 2020 – Mar 2023
Built Power BI dashboards used across all Gap brands worldwide, connected to SQL Server for live data. Automated the manual refresh process with Power Automate.
Wrote Python integrations against vendor REST APIs, supported Azure data pipeline development (Data Factory, Databricks, Data Lake), and ran requirements gathering and UAT with business stakeholders.
Power BIPythonAzureSQL
Skills
Regulated Systems
GxP Validation & Compliance21 CFR Part 11Computer System Validation (CSV)Change ControlSystem Testing & Validation