Commissioning & Qualification Lead - Capital Projects

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

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.