Quiet solutions. Powerful results.
From advanced process simulation (Aspen Plus, COMSOL, MATLAB) to GMP validation and technical cleanliness (ISO 14644, VDA 19), we deliver efficient, audit-ready solutions for pharma, biotech, clean-tech, and energy industries.
Optivion Engineering, founded by Dr. Marko Pavlović, PhD, provides consulting in pharma, biotech, clean-tech, and energy. With 10+ years of experience, we help companies optimize processes, ensure compliance, and achieve audit-ready operations.
Our Services
Transforming complex challenges into efficient, reliable, and audit-ready solutions.
Process Simulation & Optimization
🛠Advanced Aspen Plus, COMSOL, MATLAB modeling, DoE/QbD, hybrid ANN+GA optimization, energy & cost analysis.
Pharma & Biotech Consulting
🧪 GMP compliance (EU/FDA/EMA), Annex 1 readiness, validation (IQ/OQ/PQ, PPQ, CPV), cleaning validation, CSV & Data Integrity (21 CFR Part 11).
Technical Cleanliness
🧼 VDA 19 & ISO 16232 compliance, technical cleanliness audits, GAP analysis, clean zone strategies, particle monitoring & staff training.
Quality Assurance & Audit Readiness
📋 Internal audits, audit preparation, CAPA systems, continuous improvement support.
Project & Process Management
📈 Process transfer, scale-up, risk assessment, technical project leadership.
Training & Knowledge Transfer
🎓 Workshops, staff training, and technical coaching in GMP, technical cleanliness, and process optimization.
About us
Optivion Engineering is a consulting firm specialized in pharma, biotech, clean-tech, and energy industries. Founded by Dr. Marko Pavlović, PhD, we combine advanced process simulation, GMP compliance expertise, and technical cleanliness solutions to help companies achieve reliable, efficient, and audit-ready operations.
With over 10 years of multidisciplinary experience, we have delivered:
Cleanroom validations (ISO 14644) for battery production facilities,
Hybrid Aspen Plus + ANN/GA modeling for phosphoric acid processes,
GMP validation projects (IQ/OQ/PQ, CPV) for pharmaceutical production lines.
Our mission: transform complex engineering and regulatory challenges into practical, measurable results.
Proven Expertise
10+ years of multidisciplinary experience in pharma, biotech, and clean-tech.
Regulatory Excellence
Deep knowledge of GMP, Annex 1, VDA 19 & ISO 16232 compliance.
Innovative Approach
Hybrid modeling, process optimization & AI-driven solutions.
Reliable Results
Efficient, audit-ready, and sustainable solutions tailored to your business
Why Choose Us
At Optivion Engineering, we combine advanced process simulation, GMP compliance expertise, and technical cleanliness solutions to deliver measurable results. Our clients trust us to transform complex engineering and regulatory challenges into efficient, reliable, and audit-ready operations.
Our Experience
With over a decade of multidisciplinary expertise, Optivion Engineering has successfully delivered projects in pharma, biotech, clean-tech, and energy industries. Our experience spans process simulation, GMP validation, and technical cleanliness – ensuring efficient, compliant, and audit-ready operations for our clients.
Case Studies
📌 Case Study 1 – Pharma Validation Project
Full GMP validation for a new pharmaceutical production line, including IQ/OQ/PQ protocols and cleaning validation.
Result: Successful regulatory inspection with zero major findings.
📌 Case Study 2 – Process Simulation & Optimization
Developed a hybrid Aspen Plus + ANN/GA model for phosphoric acid production.
Result: 12% cost reduction and improved energy efficiency.
📌 Case Study 3 – Technical Cleanliness Implementation
Implemented VDA 19 compliance and contamination monitoring in a battery production environment.
Result: 30% reduction in particle contamination and improved audit readiness.
Turning complex engineering and compliance challenges into measurable results.
Our Consultants
DR.MARKO PAVLOVIC,PhD
Founder & Lead Consultant
📍 Specialization: Process Simulation, GMP Validation, Technical Cleanliness 📍 10+ years of multidisciplinary experience in pharma, biotech, clean-tech, 📍 PhD in Chemical Process Engineering
Founder’s Note
Ready to Optimize Your Processes and Ensure Compliance?
🔧 Optivion Engineering is currently in preparation. Official opening – January 2026.
Optivion Engineering
Quiet solutions. Powerful results.
Engineering consulting in pharma, biotech, clean-tech, and energy industries. From process simulation to GMP validation and technical cleanliness – reliable, efficient, and audit-ready solutions.