Process Engineer QA

Robert Walters Spain; Barcelona; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

Una destacada empresa en el área de Ciencias, Investigación y Biotecnología busca un Ingeniero de Validación para unirse a su equipo en Barcelona. Serás responsable de garantizar el funcionamiento óptimo del sistema de gestión de calidad, supervisando procesos de validación y capacitación del personal. Este puesto ofrece una excelente oportunidad de desarrollo profesional en un entorno dinámico y colaborativo.

Formación

• Bilingual proficiency in English and Spanish.
• Experience in quality management systems and manufacturing processes.
• Courses in ISO standards and validation preferred.

Responsabilidades

• Manage the validation master plan and calibration program.
• Draft and review QMS documentation.
• Monitor the progress of validation plans and maintain KPIs.

Conocimientos

Detail-oriented

Analytical

Proactive

Meticulous

Communication

Leadership

Organized

Educación

B.S. in Industrial Engineering

Herramientas

ERP

Microsoft Office

Descripción del empleo

Responsible for the achievement of the validation master plan and the calibration programme to ensure the effectiveness of the QMS and ensure the proper functioning of the internal calibration laboratory.Work alongside product managers, project managers, and developers to ensure quality is maintained at every lifecycle stage through active participation in the management of the QMS processes based on current legislation and regulations focused on processing risk analysi.

- Drafting and reviewing, as applicable, documentation related to QMS processes; bilingual English-Spanish or one of both with preference for English.

- Participate in the maintenance of risk analysis of QMS processes.

- Track and maintain key performance indicators (KPIs).

- Frequently inspect the production plant to verify on-site process control and compliance with procedures, as well as train if necessary staff on modifications to be made.

- Organize and convene quality meetings as required to ensure that the effectiveness of the Quality Management System is maintained.

- Identify and propose opportunities for improvement of the Quality Management System.

Your tasks include, but are not limited to:

Related to manufacturing transfer process :

- Transfer from design to production regarding control plans/control methods.

- Training of factory personnel.

- Support to design and construction of test rigs for design and/or manufacturing.

- Change controls relating to in-house and subcontracted manufacturing process (assembly, control).

Related to validation process :

- Writing protocols, participating in the execution and reporting of validations; bilingual English-Spanish or one of both with a preference for English.

- Monitoring the progress of the validation plan and reporting to your manager.

- Preparation of validation maintenance reports and monitoring of equipment, facilities and services; evaluation of trends.

- Validation of clean rooms.

- Validation of ethylene oxide and wet steam sterilisation systems.

- Validation of computerised systems.

- Drafting and reviewing, as applicable, documentation related to QMS processes; bilingual English-Spanish or one of both with preference for English.

- Participate in the maintenance of risk analysis of QMS processes.

- Track and maintain key performance indicators (KPIs).

- Frequently inspect the production plant to verify on-site process control and compliance with procedures, as well as train if necessary staff on modifications to be made.

- Organize and convene quality meetings as required to ensure that the effectiveness of the Quality Management System is maintained.

- Identify and propose opportunities for improvement of the Quality Management System.

Education:

Bachelor's degree in Industrial Engineering (preferably).

Courses or specialization preferred in (not required):

- ISO 14644: Clean rooms.

- ISO 11135: Sterilisation of medical devices. Ethylene oxide.

- ISO 14937: Sterilisation of medical devices.

- GAMP5 for the validation of computerised systems.

- GMP and validation related regulations.

- Microbiology.

- Metrology.

- English complete professional competence.

- Advanced Microsoft office user.

- Used to work in ERP environments.

Skills:

Detail-oriented but also understand the big picture.

Analytical, proactive and collaborative person.

Meticulous, efficient, rigorous, dynamic and organized.

Person with leadership and communication skills.

Tipo de contrato: FULL_TIME

Especialización: Pharma, Healthcare & Biotech

Área: Medical R&D

Sector: Ciencia e Investigación

Banda salarial: Negotiable

Tipo de trabajo: Presencial

Nivel de experiencia: Associate

Idioma principal: Español - Trabajo profesional

Idioma secundario: Inglés - Trabajo profesional

Ubicación: Barcelona

FULL_TIME

Referencia: BYDHM8-C6CC4522

Fecha de publicación: 30 de mayo de 2025

Consultor/a: Paula Crespo

barcelona healthcare-biotech/medical-research 2025-05-30 2025-07-29 science-and-research barcelona Barcelona ES Robert Walters https://www.robertwalters.es https://www.robertwalters.es/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png true