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Staff Validation Engineer · Sequel Med Tech

Sam Dyer

I build automated, audit-ready validation for regulated software, so testing is something CI runs and not a binder somebody signs.

Fourteen years in pharma and biotech, from the chemistry bench to the test harness. Currently finishing an MS in Computer Science at Georgia Tech with a focus on machine learning.

Get in touch GitHub LinkedIn
~400 requirement-tagged Playwright tests driving live GxP tenants, no mocks
weeks → 2h MES simulator configuration, rebuilt as a schema-driven script
0 hand-maintained trace matrices; the RTM is generated and fails CI on coverage loss
14 control objectives in the validation framework standard I wrote

01

Experience

  1. Apr 2026 – PresentRemote

    Staff Validation Engineer

    Sequel Med Tech

    Built automated validation from the ground up for four GxP systems under 21 CFR Part 11 and GAMP 5: NetSuite ERP, Veeva Quality Vault, Veeva PromoMats, and Salesforce Health Cloud.

    • Own two Playwright/TypeScript suites, about 400 requirement-tagged tests in total, driving live tenants over OAuth 1.0a and SuiteQL, Entra SSO browser sessions, and the Vault REST API.
    • Replaced the hand-maintained trace matrix with machine-checked traceability (URS → functional requirement → configuration object → test). The generated RTM fails CI on coverage loss or orphan tags.
    • Wrote the company's Automated Validation Framework Standard: 14 control objectives with conformance tests and a scored report per system, so a new suite in a different stack can conform without sharing any code.
    • Configured Microsoft Copilot agents for NetSuite and Jira using their MCP servers and validated skills.
    • Playwright
    • TypeScript
    • NetSuite
    • Veeva Vault
    • Salesforce
    • MCP
  2. Aug 2024 – Apr 2026Remote

    Senior Automation Engineer

    Skellig

    Manufacturing automation and OT quality for top-tier pharma clients, including Eli Lilly and Biogen.

    • Simulated production equipment in Tulip MES, with HighByte generating process data and batch logic for integrated non-production testing.
    • Wrote a Playwright tool that builds and updates Tulip machine simulators from a definition schema where no API existed. Weeks of manual configuration became a run of about two hours.
    • Automated document retrieval from a legacy EDMS to feed an AI-assisted requirements gap analysis (Python, Gemini API, Playwright).
    • Automated user access reviews with Python and pandas, with a Streamlit front end for reviewers. Updated CSV and periodic review procedures to GAMP 5 Second Edition.
    • Tulip
    • HighByte
    • Python
    • Gemini API
    • Streamlit
  3. Nov 2022 – Jun 2024Remote

    Computer System Validation Manager

    Project Outlier · client: Aimmune / Nestlé Health Science

    CSV lead for the PMO and Compliance team, managing five people while staying a hands-on contributor.

    • Built and automated testing for integrations between Veeva and Salesforce, SAP, and Cornerstone using Python, SQL, and MuleSoft.
    • Built Pytest frameworks and coordinated data migration and verification during system transitions.
    • Pytest
    • MuleSoft
    • SAP
    • Veeva
  4. Oct 2021 – Nov 2022Remote

    Computer System Validation Engineer II

    Resilience

    CSV lead for three sites, leading eight contractors across biomanufacturing, quality, and enterprise systems.

    • Designed the validation strategy for a global Ignition SCADA platform that unified real-time manufacturing data.
    • Qualified AWS infrastructure-as-code components so qualified web services for GxP apps could be deployed quickly.
    • UI and integration testing with Pytest, Selenium, and Robot Framework.
    • Ignition
    • AWS
    • Selenium
    • Robot Framework
  5. Nov 2019 – Oct 2021Remote

    Senior Computer System Validation Engineer

    Project Outlier · client: Ultragenyx

    Ran the validation lifecycle for clinical, regulatory, and R&D systems. Led an eDRO app for clinical trial monitoring, cut test execution time for Almac IRT and CTMS, and validated cloud SAS migrations.

  6. Dec 2015 – Nov 2019Oceanside, CA

    Automation Documentation Specialist

    ValSpec · client: Genentech

    IQ/OQ/PQ and SDLC documentation for manufacturing, facilities, and automation. Validated DeltaV procedures and SQL stored procedures for Syncade MES.

  7. 2012 – 2015San Diego, CA

    Where I started: the lab

    Production Chemist II, BioLegend. Made fluorescent-conjugated monoclonal antibodies and led the team in lot completion rate.
    QC Technician, Alere. Medical device testing and batch record review, leading a team of 20.

    That's why I write tests the way a chemist writes up a method: every result traceable, every deviation explained.

02

Machine learning projects

Reinforcement learning · Finance

Algorithmic trading system

A trading bot for stock indices built on Proximal Policy Optimization, written from scratch in PyTorch. An LSTM handles the time series. I backtested it in pandas, then ran it as a live paper trader through the Alpaca API.

  • PPO
  • LSTM
  • PyTorch
  • Alpaca

Reinforcement learning · Vision

AWS DeepRacer

An autonomous racing model that uses a CNN for visual perception and PPO for continuous steering and throttle, trained in simulation.

  • CNN
  • PPO
  • AWS

Reinforcement learning · Control

Lunar Lander

A Soft Actor-Critic agent tuned for stability in the continuous Lunar Lander environment. It landed safely in 100% of evaluation runs.

  • SAC
  • PyTorch

03

Skills

Validation & engineering

  • Python
  • TypeScript
  • SQL
  • Go
  • AWS
  • Docker
  • Git
  • DeltaV
  • Ignition
  • Tulip
  • Salesforce
  • Veeva QualityDocs / QMS

Test automation

  • Playwright
  • Pytest
  • Selenium
  • Robot Framework
  • Postman
  • CI traceability

Machine learning

  • PyTorch
  • scikit-learn
  • pandas
  • NumPy
  • Ray
  • MLflow
  • Matplotlib
  • Supervised / unsupervised / RL

Compliance & delivery

  • GAMP 5
  • 21 CFR Part 11
  • 21 CFR 210 / 211 / 820
  • EU Annex 11
  • ICH Q9 / Q10
  • Risk analysis
  • Change management

04

Education

2024 – 2028

Georgia Institute of Technology

MS, Computer Science · GPA 3.7, in progress

Machine Learning for Trading, Machine Learning, Deep Learning, Reinforcement Learning

2019 – 2020

Central Methodist University

BS, Computer Science · GPA 4.0

Networking, data engineering, web and systems development

2008 – 2012

University of Missouri

BS, Medicinal Chemistry

Organic, inorganic, and physical chemistry; biochemistry

05

Let's talk.

I'm interested in validation automation, quality engineering in regulated industries, and applied ML. The fastest way to reach me is email.

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