Experteer Overview
In this role you will support and lead qualification-related activities for automated production systems, ensuring compliance with cGMP and company policies.

You will collaborate with global IT teams to uphold cybersecurity and system design standards, while managing engineering projects for production equipment.

You drive changes to maintain qualified status and handle deviations impacting qualification in manufacturing and utilities.

This is a hands-on opportunity to shape automation solutions in a growing international pharma setting.

You will work closely with cross-functional teams to enable reliable, compliant manufacturing that supports allergy therapies.

Compensaciones / Beneficios
• Support areas with qualified systems and ensure compliance with corporate and site policies
• Lead qualification-related changes when modifications affect qualified status
• Perform initial qualifications of computerized equipment and systems
• Maintain qualified status through periodic reviews per evaluated frequency
• Assist in handling deviations affecting qualification in production and utilities
• Manage scope, deliverables, schedule, budget,



and quality of engineering projects for cGMP production equipment and systems
• Oversee design, implementation, and qualification of automation systems
• Enforce compliance with local, state, and federal regulations to protect company reputation
• Collaborate with integral IT teams to meet cybersecurity policies and global design standards

Responsabilidades
• Degree in Engineering, Electronics and industrial automation, or related technical field
• 2–3 years in pharmaceutical engineering or validation roles
• Knowledge of GMP and qualification principles
• Knowledge of production OT systems and IT architectures
• Ability to work with Quality Systems and regulatory requirements (CFRs, GMP, FDA, OSHA)
• Experience with systems, utilities and production equipment
• Strong documentation and organizational skills
• Ability to lead technical changes and manage cross-functional communications
• English: advanced

Requisitos principales
• competitive salary package
• career development opportunities
• continuous trainings
• health insurance
• subsidized meals
• pension plan

📌 Automation Specialist (España)
🏢 Alk Abello
📍 España