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 general IT teams to ensure adherence to corporate cybersecurity policies and global system design standards.
Your profile:
Education: Degree in Engineering, Electronics and industrial automation, or related technical field.
Experience: Minimum 2–3 years in pharmaceutical engineering or validation roles.
Knowledge of GMP and qualification principles.
Knowledge in production OT systems and IT architectures.
Ability to work with Quality Systems and regulatory requirements such as: CFRs, GMP, FDA, OSHA
Experience with systems, utilities and production equipment.
Strong documentation and organizational skil
📌 Automation Specialist (Madrid)
🏢 ALK
📍 Madrid