Ll01-041524 Validation Specialist (Temperature Mapping Project)

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:

• Validation Specialist (Temperature Mapping Project)

Qualifications:

• Bachelor's Degree in Science or Engineering.

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

• 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 Temperature Mapping is a must.

• Design Documentation (URS, DS), FQ, 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 (according to related area).

• Technical Writing skills and investigations processes.

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