Engineering/Manufacturing

Facility design

• Planning and designing manufacturing plants, including clean rooms and laboratories
• Managing HVAC (heating, ventilation, and air conditioning) systems to maintain controlled environments

Equipment maintenance

• Regular maintenance and repair of production equipment
• Calibration and validation of machines to ensure proper functioning

Process optimization

• Continuous improvement of manufacturing processes to increase efficiency and reduce costs
• Implementation of advanced technologies like automation and process control systems

Regulatory compliance

• Ensuring all manufacturing and engineering activities comply with international regulations and standards, such as those defined by the FDA (Food and Drug Administration) and EMA (European Medicines Agency)
• Preparing for audits and regulatory inspections
  • Expertise in CMC statistics, programming, and report writing
  • Deep expertise in USP and DSP in GMP or MSAT environments

Development of new technologies

• Research and development of new manufacturing techniques and equipment
• Integration of biotechnology and nanotechnology into pharmaceutical production processes