Are you looking for an exciting opportunity to develop your manufacturing skills in a growing, international pharmaceutical company? At ALK, we are on a mission to improve the lives of people living with allergies, and we are seeking a dedicated and driven Automation Specialist to join our Automation Department.

Your key responsibilities:

Automation Specialist supports all production activities regarding automated processes, systems and equipment on-site to ensure work is performed and ensures compliance with corporate requirements and site policies. Key responsibilities include:
- Provide support to the areas associated with qualified systems.
- Lead changes related to qualifications when modifications affect the qualified status of equipment or systems.
- Perform initial qualifications of computerized equipment and systems.
- Ensure qualified status is maintained through periodic reviews according to evaluated frequency.
- Provide support in handling deviations, especially those impacting the qualified status of equipment in production and utilities areas.
- Manages the scope,



deliverables, schedule, budget and quality of engineering projects related to cGMP production equipment and systems.
- Manages the design, implementation, and qualification of automation systems.
- Maintains company reputation by enforcing compliance with local, state and federal regulations.
- Work closely with global IT teams to ensure adherence to corporate cybersecurity policies and integral system design standards.
- Prepares and develops User Requirement Specifications for automated equipment, software, and systems.
- Supports QA/validations through preparation of design documents and protocol review.
- Recommends and manages implementation of appropriate corrective/preventative actions for existing equipment and manufacturing processes.
- Experience on Automation Systems and processes; involved in different phase of Definition, deployment, integration or qualifications:
- Development

📌 Automation Engineer (Madrid)
🏢 Alk-Abelló, A/S
📍 Madrid