Automation Specialist

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.

Your profile:

• Education: Degree in Engineering, Electronics and industrial automation, or related technical field.
• Experience: Minimum 2–3 years in pharmaceutical engineering or validation roles.
• Knowledge of GMP and qualification principles.
• Knowledge in production OT systems and IT architectures.
• Ability to work with Quality Systems and regulatory requirements such as:  CFRs, GMP, FDA, OSHA
• Experience with systems, utilities and production equipment.
• Strong documentation and organizational skills.
• Ability to lead technical changes and manage cross-functional communication
• English: advanced

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.