Automation Engineer

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 global 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 of projects of Automation, Control and Instrumentation (PLCs, sensors etc).


• Lean Manufacturing and Historical data Systems (KPIs).


• Software Management and Support for production equipment, vision systems, labelling, and Packaging.


• Evaluates, approves, prepares and executes change control documentation and validation documentation.


• Acts as Subject Matter Expert during regulatory inspections.


• Maintains clean and safe working environment by enforcing SHE policies and procedures.


• Maintains company reputation by enforcing compliance with local, state and federal regulation.

• Education: Degree in Engineering, Electronics and industrial automation, or related technical field.


• Experience: 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.


• Knowledge in production OT systems and IT architectures.


• Experience with systems, utilities and production equipment.


• Demonstrate proficiency with industry project management practices and tools.


• Strong documentation and organizational skills.


• Ability to lead technical changes and manage cross\-functional communication.


• Ability to analyze data and make conclusions based on the data


• Able to work in a team across departments and sites


• Clear understanding of other team members roles and responsibilities


• Ability to represent the department or organization in local and global projects with assistance from other cross functional team members.


• Identifies opportunities for improvement and makes constructive suggestions for change to improve both project management and/or process effectiveness.


• Demonstrate initiative and good interpersonal skills, able to work in a team.


• Ability to work with Quality Systems and regulatory requirements such as: CFRs, GMP, FDA, OSHA.


• Demonstrated ability to comply with required safety practices.


• Understanding of validation principles and applications for computer systems, equipment and PLC’s.

• Competitive salary package.


• Career development opportunities and continuous trainings.


• Stable employment and a positive work environment.


• A comprehensive benefits package including health insurance, subsidized meals, and a pension plan.

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Region:

• Comunidad de Madrid

Job type:

Permanent

Working hours:

Full\-time

Working days:

Day

Industry sector:

Maintenance/Technical support

Job level:

Employee

Position type:

Engineer

Application deadline:

30/09/2026

Location:

Madrid, Spain

Company homepage:

www.alk.net

Office address:

Calle Miguel Fleta 19, 28037 Madrid

Office location:

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