14 sep
|
Alk-Abelló, A/S
|
Madrid
14 sep
Alk-Abelló, A/S
Madrid
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 general 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 Engineer (Madrid)
🏢 Alk-Abelló, A/S
📍 Madrid