Qualification Engineer for Pharmaceutical Plants Specialist

1 settimana fa


Latina, Lazio, Italia VTU A tempo pieno

Job Summary

We are seeking a highly skilled Qualification Engineer to join our team at VTU. As a Qualification Engineer for Pharmaceutical Plants, you will be responsible for the commissioning and qualification of pharmaceutical plants, as well as their design.

Key Responsibilities

  • Project management and project execution
  • Development of User Requirements Specifications (URS), System Layout and Installation Arrangements (SLIA), and Cleaning and Layout Installation Arrangements (CLIA)
  • Elaboration of qualification protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Preparation of validation summary reports and traceability matrices
  • Conducting risk assessments and commissioning of plants
  • Qualification and validation activities for core business equipment and clean utilities, in accordance with Good Manufacturing Practice (GMP) regulations
  • Implementation of process design and calculations in various project phases
  • Preparation of Process Flow Diagrams (PFDs) and Piping and Instrumentation Diagrams (P&IDs)
  • Implementation of customer requirements and preparation of tender documentation and supplier alignment

Requirements

  • Degree in Process Engineering or a related field
  • Proven experience in the Pharmaceutical Industry or a process engineering company with significant experience in the pharmaceutical or biotech field
  • Ability to work independently and as part of a professional team

What We Offer

  • Varying and challenging tasks in a dedicated team
  • Excellent working environment
  • Flexible working hours
  • Internal and external training opportunities


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