19+ GMP Manufacturing and CDMO sites Supported World-Wide
Capital Projects, Regulatory Compliance, Transformation/Scale-Ups, Operational Excellence
$4.25B+ in Asset Value Delivered & Supported
Strategic planning and flawless execution for high-stakes infrastructure expansions and Operational Readiness
100% Regulatory Compliance (FDA, EMA, PMDA, TGA, ANVISA)
Trusted audit support, inspection readiness, and program management across all clients.
26+ Years of Hands-On & Executive Industry Experience
Leadership that blends deep hands-on expertise with executive-level strategy—ensuring excellence and accelerating progress
Core Capabilities
Facility Design & Engineering
Designing and engineering GMP-compliant pharmaceutical and biotechnology facilities, from initial concept to operational readiness.
Commissioning & Qualification (CQV)
Planning, executing, and documenting commissioning and qualification activities to verify that systems and equipment meet design and regulatory requirements.
Process Scale-Up & Tech Transfer
Providing leadership and support in process transfers and scale-ups, ensuring quality and compliance at every stage
Transformation & Operational Readiness
Preparing facilities, processes, and staff for operational startup following construction, renovation, or other critical changes.
Leading organizations and supporting them in readying their teams, processes, and documentation to excel in inspections and achieve critical regulatory milestones.
Project Management
Overseeing scope, schedule, budget, and resources with an absolutely NO-SURPRISES —ensuring every project is delivered on time, within requirements, and with complete transparency.
Global Experience
Tomas Krupicka
Tomas Krupicka is recognized as a trusted leader and transformation catalyst in the pharmaceutical and biotechnology industries. Over the course of his career, he has guided companies through complex capital projects, operational scale-ups, and post-acquisition integrations—always ensuring the highest standards of GMP compliance and regulatory readiness.
Known for blending executive vision with hands-on technical expertise, Tomas works side-by-side with teams to deliver world-class facilities, streamline operations, and build resilient organizations that thrive under pressure. Through ENGINEEX LLC, he continues to help clients navigate challenges, seize opportunities, and achieve lasting success.
ENGINEEX doesn’t just build and scale facilities and organizations — it builds trust, compliance, and innovation into every step of the process.
- Tomas Krupicka, Founder & Principal Consultant