Operational Excellence × AI × Manufacturing

Nikhil Pal

Building better manufacturing systems — before automating them.

I lead Business Excellence across Roche External Manufacturing: 180+ contract manufacturers, none of them reporting to me, all of them expected to deliver. Before that, 16 years on electronics and biologics floors in India, Malaysia and Singapore. The lesson has not changed once. Fix the process, then buy the software.

Nikhil Pal
16years in manufacturing operations
4countries India, Malaysia, Singapore, Canada
3industries Electronics, biotech, pharma
  • Pharma
  • Biotech
  • Electronics
  • External Manufacturing
  • Smart Manufacturing

Selected impact

Numbers matter when they come from real operating problems.

Reduction in work-in-process15 complex cells converted from batch to single-piece flow, Jabil Singapore
92%
Increase in manufacturing throughputLoss analysis, standard work and flow redesign across two sites, 2015 to 2021
60%
Site productivity in roughly eight monthsBiologics scale-up through the PPI Business System, Thermo Fisher Scientific Singapore
40 → 90%
External manufacturing partners under performance governanceRoche External Manufacturing, global CDMO network
180+
Kaizen events ledAlongside 32 major Lean Six Sigma initiatives
54+
People developed through Lean Six Sigma training and coaching50+ formally certified across Green Belt and Black Belt pathways
300+

Point of view

Optimize before you automate.

I’ve seen organizations digitize broken processes and then wonder why the technology did not produce the expected result.

My rule is simple.

Every site I have worked on had a version of the same story: a tool bought to fix a problem nobody had defined. The tool worked. The problem stayed. Technology cannot repair an operating system that was never designed, and it is very good at hiding that fact behind a dashboard.

  1. 01UnderstandUnderstand the work.
  2. 02SimplifyRemove the waste.
  3. 03StabilizeStabilize the process.
  4. 04DigitizeBuild the right data.
  5. 05Intelligent automationThen automate.

AI works better when the operating system underneath it works.

Career story

16 years improving how manufacturing works.

  1. India
  2. Malaysia
  3. Singapore
  4. Canada
  1. 2023 – Present

    Mississauga, Canada

    Current

    Hoffmann-La Roche Ltd.

    Principal Business Excellence Manager, External Manufacturing

    • External Manufacturing
    • Operational Excellence
    • Business Excellence
    • CDMO performance
    • CHF 400K+ in hard savings delivered through workflow standardization, process redesign and automation.
    • Zero stockouts, zero backlog and zero write-offs in the tracked external artwork process after redesign.
    View details

    I lead Business Excellence across Roche External Manufacturing: 180+ contract manufacturing partners on one side, Quality, Supply Chain, Technical Operations, Procurement and Finance on the other. None of the partners report to me. The results still have to land.

    • Built and govern a CHF 52M+ cost-of-inefficiency opportunity pipeline identified across External Manufacturing, including approximately CHF 11M in supply chain optimization and CHF 5M in partner Lean opportunities, each with named owners, financial logic and milestones.
    • Redesigned the external artwork management process across ALPIN and WebCenter for a commercial biologic, reaching zero stockouts, zero backlog and zero write-offs in the tracked process after implementation.
    • Designed partner performance governance across the 180+ partner network: supplier KPIs, scorecards, operating reviews, risk escalation and corrective-action tracking that convert partner issues into decisions, owners and recovery dates.
    • Shaped digital SQDEC and tiered management routines, moved performance reporting to Tableau Cloud, built CDMO performance databases and dashboards, and led PMO for technical transfer.
    • Coach cross-functional teams in root cause analysis, A3 and Lean Six Sigma as a designated RCA mentor.
  2. 2021 – 2023

    Singapore

    Thermo Fisher Scientific

    Senior Continuous Improvement Manager

    • PPI Business System
    • Site transformation
    • Smart manufacturing
    • Productivity
    • Site productivity from roughly 40% to over 90% in about eight months during a rapid biologics scale-up.
    • OTIF improved about 40% and inventory reduced about 60% through flow redesign and pull-based replenishment.
    View details

    I joined during a rapid biologics scale-up with site productivity near 40% and revenue commitments already made. I led site-wide continuous improvement through the PPI Business System, with a team of continuous improvement and supply chain analysts.

    • Raised site productivity from approximately 40 percent to over 90 percent in roughly eight months.
    • Improved OTIF by approximately 40 percent and reduced inventory by approximately 60 percent through end-to-end flow redesign and pull-based replenishment.
    • Led warehouse and 3PL optimization generating approximately USD 95K per month in expense savings, alongside USD 230K+ in annual hard savings from smart manufacturing initiatives.
    • Reduced downtime by 30 percent and improved cycle time by 25 percent across targeted production processes.
    • Led the site-wide Quality Begins with Me program, embedding quality ownership into frontline and leadership routines; certified 8 employees to Six Sigma Green Belt.
  3. 2015 – 2021

    Singapore

    Jabil Inc.

    Plant Lean Six Sigma Manager and Factory of the Future Leader

    • Lean transformation
    • Lean Six Sigma
    • Manufacturing flow
    • Kaizen
    • WIP reduced 92% by converting 15 complex cells from batch production to single-piece flow.
    • OEE from 32% to 56% and throughput up about 60%; 54+ Kaizen events generating USD 900K+ in annual savings.
    View details

    I ran the operational excellence function for two Singapore sites with five continuous improvement specialists, across build-to-order, configure-to-order and engineer-to-order electronics. High mix, complex assembly, and mostly running in batch when I arrived.

    • Converted 15 complex manufacturing cells from batch production to single-piece flow, reducing WIP by 92 percent.
    • Improved OEE from 32 percent to 56 percent and throughput by approximately 60 percent between 2015 and 2021 through loss analysis, standard work, flow redesign and bottleneck removal.
    • Led 54+ Kaizen events and 32 major Lean Six Sigma initiatives generating USD 900K+ in annual savings.
    • Built and executed smart factory roadmaps using the SIRI digital maturity framework, connecting Lean foundations with IoT, MES, automation and predictive analytics.
    • Led the Behaviour Based Quality program, moving quality from inspection thinking to observable behaviors embedded in leader standard work and daily management.
    • Developed 300+ employees through Lean Six Sigma training and coaching; 50+ formally certified across Green Belt and Black Belt pathways.
  4. 2010 – 2015

    India and Malaysia

    Jabil Inc.

    Senior Industrial Engineer

    • Industrial engineering
    • Process design
    • Work measurement
    • Ergonomics
    • Cycle time reduced about 15% through MOST implementation and SIMO motion analysis.
    • Throughput up about 20% through work cell redesign, line balancing and flow optimization.
    View details

    My first job. Time studies, MOST analysis, motion analysis, ergonomics and line balancing on electronics assembly lines in India and Malaysia. It is where I learned to watch the work before changing it.

    • Reduced cycle time by approximately 15 percent through MOST implementation and SIMO motion analysis in assembly operations.
    • Improved throughput by approximately 20 percent through work cell redesign, line balancing and flow optimization.
    • Built an overall labor efficiency tracking system for roughly 3,000 technicians.

Expertise

Where I spend my time.

  • 01

    Operational Excellence

    Daily management, flow and structured problem solving, built so the gains hold after the project team leaves. At Jabil that meant 15 cells moved from batch to single-piece flow and WIP down 92%.

  • 02

    Business Excellence

    Turning strategy into operating targets someone actually owns: a name, a cadence, a threshold, and an agreed action when it breaches. A metric nobody owns is decoration.

  • 03

    AI & Digital Transformation

    Deciding where AI belongs in a plant, and where it doesn't yet. I build and test AI tools for root cause and investigation work, and I say no to automating a process that still runs three ways on three shifts.

  • 04

    Smart Manufacturing

    Sensing, dashboards and decision support installed on top of a process that is already under control. I built SIRI-based smart factory roadmaps at Jabil and moved Roche partner reporting onto Tableau Cloud.

  • 05

    External Manufacturing

    Getting results from CDMOs and partners you don't employ. Scorecards people believe, operating reviews that end in decisions, and escalation paths agreed before you need them.

  • 06

    Lean Six Sigma

    DMAIC, A3 and Kaizen, plus the discipline to point them at the right problem. 54+ Kaizen events, 300+ people trained, 50+ certified. The practitioners outlast the projects.

Operational Excellence + AI

AI won’t fix a broken process.

The biggest manufacturing opportunity is not adding AI everywhere.

It is deciding where AI belongs, and where basic operating discipline has to come first. I don’t build models. I make the process underneath them worth automating, which is slower, less exciting, and the only version I have seen pay back.

  1. 01Lean foundation
  2. 02Digital process
  3. 03AI-assisted decisions
  4. 04Autonomous operations

Each layer depends on the one below it. Skipping a layer moves the failure downstream.

  • 01

    AI-Assisted Problem Solving

    Deviation reports, maintenance logs and shift notes hold more root causes than any dashboard. I use AI to read them faster and to sharpen the problem statement before a team spends a week on the wrong one.

  • 02

    Process Intelligence

    Event data from MES and ERP shows where batches wait, where they loop back and where variation hides. The tool finds the pattern. Someone still has to walk the line to confirm it.

  • 03

    Smart Manufacturing

    Sensors, connected equipment and real-time KPIs, added where a stable process can use them. Where the process isn't stable yet, I would rather have a whiteboard.

  • 04

    AI-Ready Operations

    Standard work, a named owner for every process, clean data and clear decision rules. Boring on purpose. It is the only foundation intelligent automation has ever worked on for me.

“Technology should serve the process. The process should serve the customer.”

Speaking

Practical conversations about manufacturing, quality and AI.

  1. 01

    Quality 4.0 Starts Before AI

    Why Most Quality Systems Aren't Ready

  2. 02

    AI Won't Fix a Broken Process

    The Operational Discipline Behind Successful AI Transformation

  3. 03

    From Automation to Autonomous Operations

    The Operational Excellence Layer Nobody Talks About

Nikhil Pal at ISPE Canada, 2026
ISPE Canada, 2026

Recent and upcoming

  • ISPE Pharma 4.0 & Biopharma Conference

    December 2026 · Berlin, Germany

  • ASQ Toronto Conference

    September 2026 · Toronto, Canada

    “Quality 4.0 Starts Before AI: Why Most Quality Systems Aren't Ready”

  • ISPE Canada

    June 2026 · Canada

    “From Pharma 4.0 to Pharma That Works: Embedding AI Inside Daily Operations”

Book cover: Business Process Improvement in the Age of AI by Nikhil Pal

Author

Business Process Improvement in the Age of AI

Second edition, available now

I wrote this book because I kept seeing the same split. Lean people treating AI as hype. AI people treating Lean as a museum piece. Both are wrong, and the plants that win will be run by people fluent in both.

It is built around a four-stage sequence I have used in four countries: Standardize, Optimize, Automate, Sustain. And one working rule that has not let me down yet: your process is the prompt.

Coming soon: AI-Powered Lean Six Sigma: Transforming Smart Manufacturing for the Next Decade

Professional foundation

Credentials that sit behind the operating results.

  • Villanova University Lean Six Sigma Master Black Belt badge
  • ASQ Certified Six Sigma Black Belt badge
  • PMI Project Management Professional badge
  • Prosci Certified Change Practitioner badge
  • TÜV SÜD Industry 4.0 badge
  • PEX Network Top 50 Leaders in Business Transformation 2025 badge
  • Thinkers360 Top 10 Thought Leader, Manufacturing badge

Certifications

  • Lean Six Sigma Master Black Belt, Villanova University
  • ASQ Certified Six Sigma Black Belt (CSSBB)
  • Project Management Professional (PMP), PMI
  • Prosci Change Management Practitioner
  • Certified ScrumMaster (CSM), Scrum Alliance
  • Industry 4.0, TÜV SÜD
  • Shingo Institute member

Education

  • PhD candidate, Management Sciences and Engineering

    University of Waterloo, Canada

    Part-time, in progress. Data-driven operational excellence in regulated manufacturing.

  • MBA, Manufacturing Management

    BITS Pilani, India

    2016

  • Bachelor of Engineering, Mechanical Engineering

    Dr. Babasaheb Ambedkar Marathwada University, India

    2009

Recognition

Nikhil Pal

About

Practitioner first. Everything else follows.

My first job was time studies on an electronics line in India. Sixteen years later I run Business Excellence across a Roche network of 180+ contract manufacturers, and the core of the job has not moved: find out how the work actually happens, then fix that before touching anything else.

In between, I converted batch cells to single-piece flow in Singapore, took a biologics site from 40% to over 90% productivity in about eight months, and learned how to get results in companies where nobody reports to me.

Somewhere along the way I started writing about AI. Not because it excites me. Because I kept watching plants automate a process they had never stabilized, and then blame the tool.

I write and speak about adopting new technology without throwing away the fundamentals that made improvement stick in the first place.

“The floor tells you things the dashboard cannot.”

Contact

Let’s talk about what’s next.

  • 01

    Executive opportunities

    A Director or Head of Operational Excellence seat in regulated manufacturing, ideally with a partner network or matrix that does not report to it. That is the problem I have been solving for three years.

  • 02

    Speaking

    A conference, a leadership offsite or a chapter meeting that wants real cases and real numbers, including the ones that did not work the first time.

  • 03

    Advisory & collaboration

    A manufacturing, Operational Excellence or AI question where you want a practitioner's view before you commit budget.