JOB DESCRIPTION

Simplrea project

Role: requires:
Availability to work extended shifts (8- 12 hours per shift)​
Availability to work weekends (Saturday and/or Sundays)​
Availability to work Holidays as require​
Availability to work first and / or second shift (If require) mainly first shift​
Minimum 2 years in experience in Process Validation and / Computer System Validations​​
1 Quality Engineer (QE) from Client will approve all documentation​
Use Client Quality Systems & Validation Templates​

Education: Engineering Degree
Years of experience: 2 +plus year in validation process
Position will be onsite/full-time

Must have:
Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning processes) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory)​

Basic knowledge in defining validation strategies (e.g requirements flow down from design to manufacturing)​

Experience with Risk management documentation: pFMEAs​

Basic knowledge in statistics (preferably using Minitab)​

Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence)​

Engineering degree: Mechanical, Electrical or Chemical preferred.


Preferences:
Experience investigating manufacturing operations events in support to product disposition​

Experience assessing and tracing manufacturing defects/rejects trends​

Knowledge in Medical Devices regulations​

Experience working and executing Design transfer activities

**Weil Group is proud to be an Equal Employment Opportunity Employer.*