Automation Engineer – Pharma Manufacturing & Qualification Lead

ALK; Madrid; Presencial; EUR 50.000 - 70.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Subsidized meals

Pension plan

Descripción de la vacante

ALK is seeking an Automation Specialist to strengthen our Automation Department. The role focuses on supporting production activities related to automated processes, systems and equipment on-site, ensuring compliance with GMP and company policies.

You will lead qualifications changes, perform initial qualifications, and work with global IT teams on cybersecurity and standards. Ideal candidates have a degree in Engineering and minimum 5 years in pharmaceutical engineering/validation, with strong

Formación

• Degree in Engineering, Electronics and industrial automation or related technical field.
• Minimum 5 years in pharmaceutical engineering or validation roles.
• Proven ability to understand and follow written and verbal instructions in English.
• Knowledge of GMP and qualification principles.

Responsabilidades

• Support production activities for automated processes, systems and equipment on-site.
• Lead qualification changes when modifications affect qualified status.
• Perform initial qualifications of computerized equipment and systems.
• Maintain qualified status via periodic reviews and frequency evaluations.
• Assist with deviations impacting equipment qualification in production/utilities.
• Manage scope, deliverables, schedule, budget and quality of automation projects.
• Design, implement, and qualify automation systems.
• Ensure compliance with local, state and federal regulations.
• Collaborate with global IT teams on cybersecurity and standards.
• Prepare User Requirement Specifications and support QA/validation activities.

Conocimientos

Automation systems

cGMP knowledge

Project management

Documentation

Data analysis

Educación

Engineering degree (Electrical/Industrial Automation)

Herramientas

PLC

Sensors

Vision systems

Descripción del empleo

ALK is seeking an Automation Specialist to strengthen our Automation Department. The role focuses on supporting production activities related to automated processes, systems and equipment on-site, ensuring compliance with GMP and company policies.

You will lead qualifications changes, perform initial qualifications, and work with global IT teams on cybersecurity and standards. Ideal candidates have a degree in Engineering and minimum 5 years in pharmaceutical engineering/validation, with strong