Pharma Automation Engineer – Qualification & Compliance

ALK-Abelló A/S; Madrid; Presencial; EUR 55.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary package

Career development and continuous培训

Stable employment and positive work环境

Benefits package: health insurance,-s1

Descripción de la vacante

ALK-Abelló A/S is seeking an Automation Specialist to join the Automation Department in Madrid. The role covers qualification, validation, and ongoing support of automation systems and production equipment in a cGMP environment.

You will lead changes, author user requirements, and collaborate with IT and QA to ensure regulatory compliance and data integrity across sites. A degree in engineering with strong English is required.

Formación

• Degree in Engineering, Electronics and industrial automation, or related technical field.
• Minimum 5 years in pharmaceutical engineering or validation roles.

Responsabilidades

• Support qualified systems and automated processes on-site.
• Lead changes related to qualifications when modifications affect equipment/system status.
• Perform initial qualifications of computerized equipment and systems.
• Maintain qualified status through periodic reviews.
• Support deviations related to qualified status in production/utilities areas.
• Manage scope, schedule, budget and quality of engineering projects for automation.
• Design, implement and qualify automation systems.
• Ensure compliance with local, state and federal regulations.
• Collaborate with global IT on cybersecurity and system standards.
• Prepare User Requirement Specifications for automated equipment/software.
• Support QA/validations with design documents and protocol reviews.
• Recommend corrective/preventive actions for equipment and processes.
• Act as SME during regulatory inspections.
• Maintain SHE and clean working environment.

Conocimientos

English proficiency

Documentation

Cross-functional communication

Project management

Data analysis

Initiative

Team collaboration

Regulatory compliance

Educación

Engineering degree (Electronics and industrial automation)

Herramientas

PLC systems

Descripción del empleo

ALK-Abelló A/S is seeking an Automation Specialist to join the Automation Department in Madrid. The role covers qualification, validation, and ongoing support of automation systems and production equipment in a cGMP environment.

You will lead changes, author user requirements, and collaborate with IT and QA to ensure regulatory compliance and data integrity across sites. A degree in engineering with strong English is required.