Automation Engineer

ALK; Madrid; Presencial; EUR 50.000 - 70.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Subsidized meals

Pension plan

Descripción de la vacante

ALK is seeking an Automation Specialist to strengthen our Automation Department. The role focuses on supporting production activities related to automated processes, systems and equipment on-site, ensuring compliance with GMP and company policies.

You will lead qualifications changes, perform initial qualifications, and work with global IT teams on cybersecurity and standards. Ideal candidates have a degree in Engineering and minimum 5 years in pharmaceutical engineering/validation, with strong

Formación

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

Responsabilidades

• Support production activities for automated processes, systems and equipment on-site.
• Lead qualification changes when modifications affect qualified status.
• Perform initial qualifications of computerized equipment and systems.
• Maintain qualified status via periodic reviews and frequency evaluations.
• Assist with deviations impacting equipment qualification in production/utilities.
• Manage scope, deliverables, schedule, budget and quality of automation projects.
• Design, implement, and qualify automation systems.
• Ensure compliance with local, state and federal regulations.
• Collaborate with global IT teams on cybersecurity and standards.
• Prepare User Requirement Specifications and support QA/validation activities.

Conocimientos

Automation systems

cGMP knowledge

Project management

Documentation

Data analysis

Educación

Engineering degree (Electrical/Industrial Automation)

Herramientas

PLC

Sensors

Vision 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.