Jobs / engineering
QA Validation Engineer - Manufacturing Systems
Abbott · Zwolle
What you will do
As a Validation Engineer Automation & Digital Systems, you will be responsible for qualification and validation activities throughout the lifecycle of equipment, processes, and systems associated with automated systems and process improvements. You will serve as a quality representative in multidisciplinary projects and help ensure compliance with internal standards and regulatory requirements.
Your responsibilities include:
- Coordinating and executing qualification and validation activities for manufacturing equipment, facilities and automated systems.
- Developing and reviewing validation protocols and reports, including IQ, OQ, PQ and Process Validation documentation.
- Supporting change control activities and assessing validation impact throughout the lifecycle of validated systems.
- Participating in risk assessments and FMEA activities.
- Collaborating with Engineering, Automation, Operations and Quality teams to ensure compliant implementation of new and modified systems.
- Supporting automated manufacturing, digitalization and continuous improvement projects.
- Maintaining validation compliance of existing systems through periodic review and lifecycle management activities.
- Monitoring project progress and validation deliverables within multidisciplinary project teams.
- Supporting audits and inspections by providing validation subject matter expertise.