Mf01-012524 Validation Engineer

Validation &Amp; Engineering Group; Ecatepec de Morelos; Presencial; MXN 1,097,000 - 1,464,000; Jornada completa

Descripción de la vacante

A leading services supplier in the life sciences sector is seeking a Commissioning and Qualification Owner for Capital Projects in Ecatepec de Morelos, Mexico. The ideal candidate will hold a Bachelor's degree in Science or Engineering and possess at least 5 years of experience within the pharmaceutical, medical device, or biotechnology industries. Responsibilities include approving documentation, overseeing protocols and reports, and ensuring compliance with high ethical standards. Bilingual proficiency in English and Spanish is required, alongside readiness for extended work hours and potential weekends.

Formación

• Minimum of 5 years of experience in direct pharmaceutical, medical device, or biotechnology industries.
• Experience with documentation such as URS, VP, DS, DQ, IQ, OQ, PQ, TMX, and reports generation.
• Knowledge of SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).

Responsabilidades

• Revise, indicate revisions and approve VP, IOPQ protocols and reports.
• Review and approve executed protocols and related documents.
• Work extended hours, including weekends and holidays.

Conocimientos

Technical Writing

Bilingual (English/Spanish)

Documentation Review

Educación

Bachelor's Degree in Science or Engineering

Descripción del empleo

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: Commissioning and Qualification Owner for Capital Projects. Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries. Experience with documentation such as URS, VP, DS, DQ, IQ, OQ, PQ, TMX, and reports generation. Knowledge of SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).

Capable of revising, indicating revisions and approving VP, IOPQ protocols and reports and reviewing and approving executed protocols and related documents. Technical Writing skills and investigations processes. Must be fully bilingual (English/Spanish) with excellent oral skills. Available to work extended hours, possibility of weekends and holidays.