Qualification Engineer for Pharmaceutical Plants Specialist
1 settimana fa
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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