Lead Validation Engineer - Pharma/Biotech (EN/ES)

Validation & Engineering Group; Ecatepec de Morelos; Presencial; MXN 400,000 - 600,000; Jornada completa

Descripción de la vacante

A leading services supplier in the pharmaceutical sector is seeking a Commissioning and Qualification Owner for Capital Projects. The ideal candidate must have a Bachelor's Degree in Science or Engineering, at least 5 years of experience in the pharmaceutical or biotechnology industries, and be fully bilingual in English and Spanish. The role requires strong technical writing skills, expertise in documentation, and availability for extended hours, including weekends and holidays.

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

• Commissioning and Qualification Owner for Capital Projects.
• Review and approve executed protocols and related documents.
• Indicate revisions and approve VP, IOPQ protocols and reports.

Conocimientos

Technical Writing skills

Bilingual (English / Spanish)

Risk Assessment

Data Integrity

Educación

Bachelor's Degree in Science or Engineering

Herramientas

Documentation (URS, VP, DS, DQ, IQ, OQ, PQ, TMX)

Descripción del empleo

A leading services supplier in the pharmaceutical sector is seeking a Commissioning and Qualification Owner for Capital Projects. The ideal candidate must have a Bachelor's Degree in Science or Engineering, at least 5 years of experience in the pharmaceutical or biotechnology industries, and be fully bilingual in English and Spanish. The role requires strong technical writing skills, expertise in documentation, and availability for extended hours, including weekends and holidays.