JT468 - VALIDATION ENGINEER II

Quality Consulting Group • Juncos, PR

6d

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 investigating manufacturing operations events in support to product disposition.
• Experience assessing and tracing manufacturing defects/rejects trends.
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees