Validation Engineer
Tychy Validation Engineer
Tychy
NR REF.: 1129231
Validation Engineer
Tychy
Essential Functions:
Skills and Abilities:
Tychy
NR REF.: 1129231
Validation Engineer
Tychy
Essential Functions:
- 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
Skills and Abilities:
- 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
- strong communication, teamwork and organizational skills
- Demonstrated ability to think out of the box and recommend options
- 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
- Some programs may have vision requirements
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
