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Test and Validation Engineer

Termin ważności:
2019-08-21 - 2019-11-14
Województwo / region:
Mysłowice, slaskie
Firma:
ukryte

For our Client - international new greenfield company based near Tychy and Mysłowice, we are looking for Validation Engineer. 

Key responsibilities:

  • Use knowledge of FDA cGMP and related regulations and guidelines and specific knowledge of validation methodologies and principles to perform validation on a variety of systems
  • Co-ordination of site validation activities as per corporate NPI process and internal Quality Management systems
  • Computer systems validation
  • Coordinate, direct and lead validation efforts including: Process, Computer System Validation, Equipment and Instrumentation Qualification, Test Method Validation, and Facility and Utility Qualification
  • Compile and analyze validation data, write/review/approve protocols, reports and make recommendations for changes and/or improvements
  • Facilitate and/or support validation training, change control, periodic review of validated systems, equipment, and processes and support change management.
  • Functions as a liaison with project engineering, manufacturing and the customer regarding validation
  • Work as part of a team to achieve targets and push for maximum production
  • Help in the manufacturing and design of new and updated equipment
  • Interface with customers on a regular basis to resolve issues
  • Extended travel to other facilities may be required to support business needs

Required qualifications: 
  • B.Sc. or B.A. degree in engineering, applied science, or related field with engineering and process validation experience
  • English on minimum B2 level 
  • Strong and diverse validation skills, including statistical analysis and presentation of related data (e.g. minitab).
  • Ability to manage multiple large-scale projects, develop and meet project schedules, along with contingency plans
  • Demonstrated broad understanding of technologies used in medical device and consumer product manufacture
  • Ability to effectively present information and respond to questions from group of managers, sales, and customers

Offer:
  • possibility to develop in new structures 
  • international team
  • benefits 
  • greenfield project 


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