Automation and Commissioning Projects in the Pharmaceutical and Biotech Industry

Completed Actions:

• ✅ Migration of obsolete automated systems
• — BMS: Desigo Insight → Desigo CC
• — SCADA/Control: IVTracer, PCVUE
• — Obsolete PLCs (Siemens S5/S7-200/S7-300, Schneider TSX/Quantum, Rockwell PLC-5/SLC-500)
• ✅ Improvement and optimization of skid programs: EPPI, GVP, TFF, chromatography…
• ✅ Equipment and machinery qualification: SAT, FAT, IQ, OQ, PQ…
• ✅ Preparation of qualification documentation: specifications, FS, qualification protocols, execution reports…
• ✅ Preventive maintenance and troubleshooting of equipment
• ✅ Execution of CAPA and Change Control management to ensure GMP (GxP) compliance
• ✅ Investigation of quality deviations and implementation of corrective and preventive measures
• ✅ Development and updating of PLC/DCS sequences (Emerson DeltaV and Siemens PCS7) for process improvement
• ✅ Process optimization and continuous improvement of traceability