Validation Engineering for Automation

Portuguese multinational with over 55 years of experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With FDA inspected sites it offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs including highly potent compounds.

For generic pharmaceutical customers the company offers niche generic API products. It also offers all customers proprietary product development and licensing opportunities for drug products. This company is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

About the project

ALTEN has contributed to the project with our experience in automation processes, validation/qualification expertise and knowledge of applicable standards and regulations. The client needed to study and validate their manufacturing processes.

Firstly, we carried out a preliminary assessment of the critical phases, taking into account the historical data. We coordinated and supervised the validation activities developing specific day to day training for the personnel involved. Finally we concentrated on drafting and defining the final processes report.

Validation Engineer is responsible for:

  • Produce validation protocols
  • Create and update Functional Specifications
  • Review Input/Output lists
  • Execute validation tests
  • Create automation operation manuals
  • Access changes impact
  • Provide the necessary training to Company employee