Job Title: Validation Engineer
This is a contract position with an 11-month duration.
Key Responsibilities:
1. Contribute to the development of New Product Introduction (NPI) projects, including project validation support.
2. Conduct risk assessments (FMEA), requirements and qualification for new equipment (URS/IQ/OQ/PQ and PV).
3. Author project validation master plans, SOP updates and documentation.
4. Author validation protocols, final reports and execute validation studies.
5. Analyze validation data, resolve technical issues encountered during study execution.
6. Work collaboratively with cross-functional teams, including engineering, production, quality assurance, supply chain and outside suppliers.
7. Maintain excellent rapport with internal/external customers.
8. Identify process bottlenecks and devise solutions to resolve them.
9. Provide hands-on support for product and process development.
10. Provide hands-on support for maintaining and fixing process equipment.
Qualifications:
* Degree: Level 8 bachelor's degree in engineering (mechanical, manufacturing etc).
* Experience: Minimum 2-5 years of experience, automated manufacturing experience an advantage.
* Equipment qualification/validation desired.