For our Client - international new greenfield company based near Tychy and Mysłowice, we are looking for Validation Engineer.
- 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
- 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
Co powinieneś zrobić?
- possibility to develop in new structures
- international team
- greenfield project
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