Validation Engineer

Flexible & Integrated Technical Services, LLC•Añasco, PR

3d•Onsite

About The Position

This role is for Validation services in the Engineering area. The ideal candidate will have a Bachelor's degree in Engineering and a minimum of three (3) years of exposure to Validation and Lean Manufacturing activities within the Pharmaceutical or Medical Device Industry. Excellent verbal and written communication skills in both English and Spanish are required. The shift is administrative and according to business needs.

Requirements

Bachelor’s degree in Engineering
Minimum of three (3) years of exposure in Validation and Lean Manufacturing activities within the Pharmaceutical or Medical Device Industry.
Excellent verbal/written communication skills (English and Spanish)
Experience in Validation Protocols
Experience in Lean Manufacturing
Experience in GMP & GDP regulations

Nice To Haves

Treats everyone they meet like family, especially our resources, clients and team members.
Customer service skills.
Innovative and eager to innovate.
Delivers top-quality results.

Responsibilities

Write, execute, and maintain on a timely basis Validation protocols.
Ensure timely, thorough, and complete execution of all protocols, meeting FDA requirements.
Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
Ensure documentation is thorough, accurate and entered on a timely basis into the quality system.
Ensures complete and thorough investigation of all product failures, batch failures and deviations associated with validation sampling and testing.
Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation requirements.
Responsible for developing and implementing process strategies, optimizing current processes, and maintaining process documents.
Support the day-to-day process operations.