Validation Technician (QC)

ONTEX México; Tijuana; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A leading company in validation management in Tijuana seeks a Validation Specialist to ensure validation processes are executed according to guidelines. The ideal candidate will have a degree in engineering and at least one year of experience in a quality or technical environment, with strong communication and analytical skills. Responsibilities include configuring protocols, leading tests, and ensuring regulatory compliance.

Formación

• 1+ year of experience in a quality, validation, or technical environment.
• Experience using metrology equipment necessary.

Responsabilidades

• Configure validation protocols for each validation process.
• Ensure compliance with validation formats.
• Participate in the execution of the validation phases.
• Lead the tests to ensure their success and report results.

Conocimientos

Effective communication skills

Analytical skills

English

Educación

University degree in engineering or a related technical field

Herramientas

Metrology equipment

Office suites

Descripción del empleo

Ensure that validation process is executed and reported according to the Ontex guidelines to ensure an effective change management and a timely implementation.

• Configure validation protocols for each validation process.
• Ensure compliance with validation formats.
• Participate in the execution of the validation phases.
• Coordinate trials and ensure that all resources and roles are available and clear about their tasks.
• Perform the extraction of samples to be evaluated.
• Coordinate with laboratory heads the execution of tests and establish priorities.
• Lead the tests to ensure their success and report the results obtained.
• Participate in the analysis and verifications of the results obtained based on the samples performed.
• Create work instructions.
• Ensure that the processes comply with the required regulations (21CFR820, ISO 9001, ISO 13485).

• University degree (or equivalent through experience) in engineering or a related technical field.
• Minimum of 1 year of experience in a quality, validation, or technical environment.
• Experience using metrology equipment.
• Effective communication skills
• Analytical skills
• English
• Proficiency in Office suites