Automation Engineer

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.