Jt319 - Validation Engineer II
Quality Consulting Group•Juncos, PR
1d
About The Position
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Requirements
- Bachelor's degree in Engineering ( Mechanical, Electrical or Chemical preferred )
- Minimum of 2 years of Engineering experience.
- Knowledge in Medical Devices regulations.
- Experience in GMP documentation.
- Experience working and executing Design transfer activities.
- Must be available to work all shifts, weekends and overtime.
- Availability to work extended shifts (8- 12 hours per shift)
Responsibilities
- Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning process) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory).
- Experience in production line.
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
51-100 employees
