Automation Engineer

ALK-Abelló A/S; Madrid; Presencial; EUR 55.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary package

Career development and continuous培训

Stable employment and positive work环境

Benefits package: health insurance,-s1

Descripción de la vacante

ALK-Abelló A/S is seeking an Automation Specialist to join the Automation Department in Madrid. The role covers qualification, validation, and ongoing support of automation systems and production equipment in a cGMP environment.

You will lead changes, author user requirements, and collaborate with IT and QA to ensure regulatory compliance and data integrity across sites. A degree in engineering with strong English is required.

Formación

• Degree in Engineering, Electronics and industrial automation, or related technical field.
• Minimum 5 years in pharmaceutical engineering or validation roles.

Responsabilidades

• Support qualified systems and automated processes on-site.
• Lead changes related to qualifications when modifications affect equipment/system status.
• Perform initial qualifications of computerized equipment and systems.
• Maintain qualified status through periodic reviews.
• Support deviations related to qualified status in production/utilities areas.
• Manage scope, schedule, budget and quality of engineering projects for automation.
• Design, implement and qualify automation systems.
• Ensure compliance with local, state and federal regulations.
• Collaborate with global IT on cybersecurity and system standards.
• Prepare User Requirement Specifications for automated equipment/software.
• Support QA/validations with design documents and protocol reviews.
• Recommend corrective/preventive actions for equipment and processes.
• Act as SME during regulatory inspections.
• Maintain SHE and clean working environment.

Conocimientos

English proficiency

Documentation

Cross-functional communication

Project management

Data analysis

Initiative

Team collaboration

Regulatory compliance

Educación

Engineering degree (Electronics and industrial automation)

Herramientas

PLC systems

Descripción del empleo

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.

Your profile:

• 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:

• 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.

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