As engineering

đź’» Get to Know Me

Hi! I’m Roberto Colón, an MES Consultant dedicated to helping manufacturers streamline operations, gain real-time visibility, and go digital with confidence. I specialize in connecting shop floor systems with business intelligence to improve traceability, compliance, and decision-making across operations.

My journey began in automation and controls engineering, where I saw firsthand how disconnected systems slow progress. That sparked my passion for Manufacturing Execution Systems, and since then, I’ve helped clients—from global pharma brands to mid-sized operations—successfully implement, upgrade, and optimize MES solutions.

With over a decade of experience in pharma and regulated industries, I understand the critical importance of data integrity, compliance, and reliable operations. My mission is to guide manufacturers through digital transformation without overwhelm—always with clarity, hands-on collaboration, and results you can measure.

🚀 What I Believe In

  • Uncompromising Data Integrity: Every batch record and report must be 100% accurate—no shortcuts.

  • Built-in Compliance: GMP/FDA requirements aren’t an afterthought; they’re baked into every workflow.

  • Scalable, Practical Solutions: Architect systems that grow with your business—pilot plant to global rollout—without costly rewrites.

  • User-First Design: If an MES feature doesn’t save seconds or reduce errors on the shop floor, it goes back to the drawing board.

  • Continuous Improvement Mindset: Go-live is Day 1—automated testing and feedback loops drive ongoing optimization.

  • Collaborative Team Building: Great results only come from great teams with the right skills—I love to work with team players like an MVP team so we can tackle big challenges and deliver major wins together.

🏆 A Few Highlights

  • 10+ years of MES leadership in biotech & pharma, delivering pilot-to-full-scale rollouts across North America and Europe.

  • 500+ EBRs developed & validated, slashing record-keeping errors by 40% and verification time by 60%.

  • End-to-end MES implementations: For clients using POMSnet or Pharmasuite, but not limited to other MES Software.

  • Support: Rapid troubleshooting, audit-ready systems, and continuous-improvement culture across multi-site operations.

  • Technical Proficiencies 
    • Languages & Scripting: C#, Python, JavaScript, SQL, C++, and C.
    • Integration & Automation: BarTender (Label design & printing workflows)
    • Platforms & OS: Linux, Windows, macOS. 
  • Future Objectives: Learning IA, Cloud Services (AWS)
Learning

Basic of MES

MES Implementation & Integration

• Service: End-to-end deployment of MES solutions (e.g., POMSnet, Werum PAS-X, Rockwell FactoryTalk).

• Value: Streamlines operations, ensures traceability, and connects ERP/MRP to the shop floor.

MES-ERP-SCADA Integration

• Service: Custom integration between MES and systems like SAP, Oracle, SCADA/PLC.

• Value: Enables real-time data flow, reduces manual errors, improves reporting and traceability.

Data Analysis & KPI Dashboards

• Service: Design dashboards for OEE, cycle time, downtime, yield, etc.

• Value: Gives decision-makers live visibility into production metrics.

Workflow & Recipe Configuration

• Service: Customizing MES workflows, recipes, and business logic to meet GMP or Lean needs.

• Value: Increases process consistency and compliance (especially in pharma/food).

Electronic Batch Record (EBR) Management

• Service: Digitize paper batch records, build EBR templates.

• Value: Critical for FDA/GMP-regulated industries; speeds up reviews and audits.

Validation & Compliance Support

• Service: CSV (Computer System Validation), GAMP 5 support, audit readiness.

• Value: Essential for life sciences and other regulated industries.

Custom Development & Scripting

• Service: Develop custom plugins, scripts, or connectors (e.g., Python, C#, SQL).

• Value: Adds flexibility and extends MES functionality to meet unique business needs.

Training & Change Management

• Service: MES user/operator training, SOP development, digital transformation guidance.

• Value: Ensures adoption and smooth transition from legacy systems.

System Audits & Optimization

• Service: Evaluate current MES usage and suggest performance or UI/UX enhancements.

• Value: Uncovers inefficiencies, ensures clients get full ROI from their MES.

Remote Monitoring & Support Services

• Service: 24/7 support, remote diagnostics, preventive maintenance.

• Value: Minimizes downtime and ensures continuous operation.

MES Software Recommendation

• Service: Recommend and implement MES platforms tailored to your industry, size, and compliance needs.

• Value: Helps select the best-fit solution (e.g., Siemens Opcenter, POMSnet, Werum PAS-X) to improve traceability, automation, and regulatory compliance.