Curtis Lui
Technical line-art illustration of a pharmaceutical rotary tablet press
Manufacturing Readiness • Process Engineering • Validation • CPV

Curtis Lui

Engineering & Technical Operations Leader

16+ years in regulated manufacturing environments. I lead complex technical programs spanning manufacturing readiness, process engineering, validation, equipment, and operational risk. These selected case studies share the thinking behind the work—how problems were framed, decisions were made, and execution was structured.

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Areas of focusManufacturing ReadinessProcess EngineeringValidationContinued Process Verification (CPV)Technology TransferTechnical Program Leadership
Organizations Worked With
  • Otsuka
  • Novartis
  • Grifols
  • Intarcia Therapeutics
  • Korsch
  • Mesa Labs
  • Mettler Toledo
  • Proditec
  • Adhesives Research
  • Sever Pharma Solutions
Selected case studies

How I Lead Complex Manufacturing Work

Illustrative GMP cleanroom with a high-volume tablet pressILLUSTRATIVE IMAGERY · NOT THE ACTUAL FACILITY
01 / MANUFACTURING READINESS

Restoring Manufacturing Readiness Following a Major Facility Change

A 12-month program with a 19-person cross-functional team. Equipment requalification and core process revalidation following facility upgrades and relocation of Manufacturing and QC operations while supporting continued clinical supply.

Program leadershipValidation strategyEquipment qualificationReadiness
PROCESS PERFORMANCE / CPVILLUSTRATIVE
From process data to technical understanding.
B1B6B11B16B21
MONITOR → INTERPRET → COMMUNICATESYNTHETIC DATA
02 / PROCESS PERFORMANCE

Developing a Risk-Based Continued Process Verification Framework

Monitoring and interpreting process performance at Grifols. Parameter criticality, trends, and technical communication—connecting observations to the right process SMEs at the right time.

CPVData interpretationProcess riskTechnical communication
A technical leadership perspective

Clarify the challenge. Align the work. Deliver the outcome.

Manufacturing problems rarely sit within a single function. My approach is to understand the technical constraint, make dependencies visible, and align specialists around a shared view of risk, priorities, and readiness. Data informs the questions; engineering judgment shapes the next step. The goal is to turn complexity into coordinated execution and better manufacturing outcomes.

How I approach technical leadership