QC Lab Equipment Validation Specialist

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Laboratory Equipment Validation Specialist

Qualifications:

Bachelor's Degree in Science or Engineering.

Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.

Experience in direct process / laboratory areas.

Must be fully bilingual (English / Spanish) with excellent oral skills.

Must be proficient using MS Windows and Microsoft Office applications.

Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.

Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.

SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).

Strong knowledge of incubators, Kaye Data Loggers, Particle Conter, TOC analyzer, Climet air sampler, Freezers, Disintegration testers.

Experience with Kneat, CDOCS, Maximo.

Technical Writing skills and investigations processes.

Available to work extended hours, possibility of weekends and holidays.

Full-time