MV02-012926 Validation Specialist

Validation & Engineering Group; Huatabampo; Presencial; MXN 400,000 - 600,000; Jornada completa

Descripción de la vacante

A leading validation services provider in Huatabampo, Mexico, seeks an Alcohol System Validation Specialist. The incumbent will support the qualification and validation of alcohol storage and distribution systems within a GMP-regulated environment. Key responsibilities include executing validation protocols, ensuring compliance with GMP and FDA standards, and collaborating with engineering teams. Ideal candidates should hold a degree in Engineering or Science and possess hands-on experience in CQV within regulated manufacturing. This role presents an opportunity to contribute to critical manufacturing processes.

Formación

• Proven experience validating alcohol storage and distribution systems in GMP environments.
• Knowledgeable in validation lifecycle and documentation practices.
• Experience in utility or process systems validation.

Responsabilidades

• Execute IQ, OQ, and PQ for alcohol systems.
• Develop and approve validation protocols and reports.
• Ensure compliance with GMP and FDA standards.
• Partner with Engineering and Quality teams on system modifications.

Conocimientos

Hands-on experience in CQV

Strong communication skills

Technical writing skills

Educación

Bachelor’s degree in Engineering

Bachelor’s degree in Science

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:

Alcohol System Validation Specialist (CQV – GMP Manufacturing)

• Alcohol System Validation Specialist to support the qualification and validation of alcohol storage, distribution, and delivery systems within a GMP-regulated manufacturing operation.

We are seeking an experienced Alcohol System Validation Specialist to support the qualification and validation of alcohol storage, distribution, and delivery systems within a GMP-regulated manufacturing operation. This role plays a key part in ensuring systems used for cleaning and sanitization meet regulatory requirements and are fit for intended use.

Key Responsibilities:

• Execute IQ, OQ, and PQ for alcohol systems, including tanks, loops, pumps, and point-of-use connections
• Develop, review, and approve validation protocols, reports, and traceability documentation
• Ensure compliance with GMP, FDA, and internal quality standards
• Support risk assessments, deviations, and change controls related to validated systems
• Partner with Engineering, Quality, and Operations during system installation and modifications
• Support audits and regulatory inspections as a system SME

Qualifications:

• Bachelor’s degree in Engineering, Science, or related field
• Hands-on experience in CQV within regulated manufacturing environments
• Strong knowledge of validation lifecycle and GMP documentation practices
• Experience validating utility or process systems (alcohol systems preferred)
• Strong communication and technical writing skills

Preferred Experience:

• Pharmaceutical, biopharmaceutical, or medical device manufacturing
• Utility systems validation (alcohol loops, WFI, clean steam, compressed gases)
• Risk-based validation approaches