Validation Engineer, Medical Devices/ Pharmaceutical
Type: FTC, occasional travel to the Southern site (expenses provided)
Duration: 12 months
Salary: Competitive DOE
Our Client, a Global Medical Devices company are looking to appoint an experienced VE to be involved in a large product and process equipment transfer project. This person will work cross functionally with the existing site in Yorkshire; with occasional travel to the Southern site.
The Successful Candidate will have:
- A Degree in a relevant Scientific or Engineering discipline
- Will have worked in a Pharmaceutical or Medical Devices setting
- Demonstrated knowledge of GMP regulations and good documentation practices is required
- Skilled in Process and equipment Validation (eg. FAT, SAT, IQ, OQ and PQ)
- Will ideally have an understanding of ISO:13485 regulations
- Experience with Lean Manufacturing principles, structured problem solving methodologies (Lean, Six Sigma, etc.) and process control.
- Practical knowledge on risk management processes (e.g. FMEA, etc.), statistical data analysis, and change control
- Experience recording and analysing data and clearly expressing conclusions and recommendation in writing
- Project Management experience with strong interpersonal and an analytical mind-set