Validation Engineer
Miejsce pracy: SzczecinFor our client, production company, we are looking:
Validation Engineer
As the Validation Engineer, you will be evaluating equipment and procedures used in production. You will be ensuring the systems are running according to necessary specifications and operating within regulations to ensure the production of highest quality products.
In particular, your area of responsibility will cover steps from defining validation processes/procedures, through execution and finally documentation of the results.
Key part of your work will be to:
- Plan, execute and document validation of processes and tools including work with Master Validation Plan
- Perform and coordinate validations within processes including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification)
- Verify validation results in cooperation with R&D departments
- Prepare and archive validation reports, supervise updates for documentation
- Assess the validation needs for tools and processes
- Suggest and implement agreed improvement solutions
- Close cooperation with Q&PE and R&D departaments
- An attractive work environment in novel production facility with an informal atmosphere, among best in class colleagues
- Competitive employment terms and benefits
- Stable employment conditions (contract of employment)
- Personal growth and development through continuous learning
- Company events
Candidate profile:
The successful candidate should possess solid technical competence – have M.Sc. in engineering and present experience within:
- Validation in the area of Medical devices and Development tools
- Knowledge of FDA requirements will be an advantage
- Preparation of documentation for validation process according to FDA requirements
- Risk assessment
- Technical documentation and reports
- Excellent English skills