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.

Siga leyendo para comprender completamente lo que este trabajo requiere en cuanto a habilidades y experiencia. Si su perfil encaja, presente su candidatura.
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:

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- 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 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.

Your profile:

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- 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.

We provide:

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- 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. xcskxlj

If you’re excited about building a better future in health, ALK is the right place for your ambitions.

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