Résumé

Martin Kockx, PE

The gap between what an organization deploys and what it can sustain is rarely a technology problem — it's an architecture problem, of data, of intent, and of the organization itself.

Belmont, MA · kockx.martin.pub@pm.me · linkedin.com/in/martinkockx

Summary

Licensed Professional Engineer and manufacturing systems architect with 13+ years across GMP biologics and cell & gene therapy. I work one stubborn problem: organizations build good systems they can't absorb. My focus is the architecture underneath — turning fragmented plant-floor systems and data into AI-ready, intent-driven foundations, and the governance and roadmaps that let smart-manufacturing and AI investments actually stick. I also write and develop the frameworks the field uses to reason about this, in collaboration with BioPhorum, ISPE, and the Pistoia Alliance.

Focus

Intent-Driven Digital Core AI Enablement & Governance Industrial DataOps & Smart Manufacturing

MES & electronic batch records (eBR) · SCADA/HMI (Ignition, Rockwell, DeltaV, GE Proficy) · OSIsoft / AVEVA PI historians · ISA-88 / ISA-95 · manufacturing ontology & semantic models · data governance & integrity (ALCOA+) · AWS · Snowflake · Databricks · AI use-case readiness & governance · 21 CFR Part 11 · EU GMP Annex 11 · GAMP 5 · computer system validation (CSV)

Experience

Principal Manufacturing Systems Engineer

Sep 2024 – Present
Vertex Pharmaceuticals — Boston, MA
Own the full lifecycle of manufacturing systems for Cell & Gene Therapy; partner with manufacturing and technology leadership to set the site's smart-manufacturing strategy and roadmap. Led end-to-end selection, deployment, and validation of a new CGT SCADA platform — vendor evaluation through IQ/OQ/PQ. Architect the manufacturing ontology and semantic/knowledge layer and drive industrial DataOps investigations to make plant data AI-ready — the working core of the intent-driven digital core. Contribute to commercial readiness and continuous batch disposition alongside engineering and quality leaders, under full GxP, data-integrity, and CSV compliance (21 CFR Part 11, EU Annex 11, GAMP 5).

Digital Plant Program Manager

2023 – 2024
MilliporeSigma — Burlington, MA
Founded and led a new global Digital Plant Program spanning 62 manufacturing facilities. Defined sector target architecture and digital strategy across MES, historian, batch, and analytics; owned the roadmap connecting plant-floor systems to enterprise data. Drove solution decisions across the program portfolio with accountability for budget, quality, and schedule.

Staff Automation Engineer

2021 – 2023
Thermo Fisher Scientific — Cambridge, MA
First operating-company role — embedded daily with manufacturing, quality, and validation, shifting from one-off deployment to full-lifecycle system ownership. Closed facility-wide equipment-integration gaps: made all equipment integratable, remotely accessible, and maintainable, and brought systems into Active Directory to cut user password load. Delivered a facility-wide alarm management system — single pane of glass with disposition and escalation-based notifications — and a centralized batch-reporting engine producing consistent reports across any vendor or system. Ran vendor evaluation and selection for an electronic batch record (eBR) system, from use-case scope and requirements through a recommended plan.

Senior Project Engineer

2020 – 2021
Constellation Brands — Napa, CA
Process and automation engineering for large-scale production operations.

Senior Controls Engineer

2019 – 2020
BW Design Group — Vacaville, CA
Lead controls engineer for life-science clients; project manager on large single-use-equipment CAPEX programs across the US.

Senior / Principal Automation Engineer

2015 – 2019
NNE (NNE Pharmaplan) — SF Bay Area, CA
West-coast Engineer of Record on greenfield biologics, single-use, and continuous-manufacturing programs; designed and implemented OSIsoft PI historian from lab to production at a commercial biotech facility.

Field / Project Engineer

2011 – 2015
Panduit — Folsom, CA (Singapore & Hong Kong posts)
Delivered data-center monitoring and control solutions, with global assignments across Asia.

Research & thought leadership

  • Intent-Driven Digital Core (IDDC) — an architectural framework for manufacturing continuity that preserves manufacturing intent from design to deployment. Conference talk, BioProcess International 2026 (Boston, Sept): "Why Architecture Must Precede Analytics." Journal and book-chapter work in progress.
  • Shadow, Sandbox & Steward — a competency-based organizational model for governing AI in regulated manufacturing. Published series; developing for PDA Journal / MIT Sloan Management Review.
  • Commissioning the Organization — an operational-readiness framework arguing that failed adoption is a readiness problem, not a technology problem. Essay series.
  • Upskilling in the Age of AI — why governance without workforce capability fails in regulated manufacturing.

Selected projects

  • Smart manufacturing roadmap & AI/data enablement (Vertex). Leading the strategy and architecture to make manufacturing data AI-ready — data enablement, governance, and a prioritized portfolio of AI use cases across the manufacturing systems estate.
  • Global Digital Plant Program — 62 sites (MilliporeSigma). Stood up a worldwide digital plant program: sector target architecture, digital strategy, and portfolio governance connecting plant systems to enterprise data and analytics.
  • Facility-wide alarm management & centralized batch reporting (Thermo Fisher). Consolidated all facility alarms into a single pane of glass with escalation notifications, and built a reporting engine producing consistent batch reports across any vendor or system.
  • Greenfield biologics PCS/BMS. Design and commissioning of a full SCADA suite, process formulation and clean-utility systems, GMP HVAC, and equipment interfaces — SDS/HDS authoring, PLC programming, FAT/SAT.
  • GMP OSIsoft PI design & implementation. Historian solution and network architecture across manufacturing lab → pilot plant → production at a major biotech facility.

Speaking & affiliations

  • Board of Directors, ISPE Boston Area Chapter (2026–present) · chapter announcement →
  • Life Science Advisory Board, IAAE (2024–present) — contributing to curriculum & direction
  • Presenter, BioProcess International 2026 — Boston, Sept 22–25
  • Panelist, American Pharma & Biotech Project Delivery & CapEx Summit 2026 — Boston, Oct 14–16 · "The Role of Project Delivery in Bringing Products to Patients Faster" · "Smart Manufacturing & Facility Modernization"
  • Contributor: BioPhorum · Pistoia Alliance  ·  Member: ISA · NSPE · Tau Beta Pi

Education & licensure

  • B.S., Mechanical Engineering — California State University, Sacramento (2010)
  • Artificial Intelligence: Implications for Business Strategy — MIT Sloan Executive Education (Apr 2026) · Credential ID 180521792
  • Licensed Professional Engineer (PE) — California, CS7550