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 integral 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.#J-18808-Ljbffr

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