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OPERATIONS - ENGINEERING/PRODUCTION
QA Project Engineer
Permanent contract
Job Description:
As a Quality Support Project Engineer within the ICS Automation department, your responsibilities will include various support tasks to ensure that computer/computerized systems remain in a validated state at all times. This is achieved through:
Operational Support
• Providing operational support in the form of advice, expertise, and knowledge of procedures to implement solutions for software and infrastructure issues as quickly as possible.
• Drawing on solid experience in software validation to determine the appropriate validation approach in accordance with procedures.
• Being responsible for coordinating validation in computer system projects.
• Defining validation approaches and writing validation plans/reports.
• Coaching Project Engineers on validation matters when needed.
• Performing risk analyses.
Periodic Review
• Responsible for carrying out the Periodic Review of all computer systems.
Data Integrity
• Data Integrity (DI) is becoming increasingly important in the pharmaceutical industry and is more than ever part of our "license to operate." In this role, you are responsible for monitoring the Data Integrity status of our automated equipment and supporting the site with questions related to Data Integrity.
Department:
• As a Center of Excellence in technology, innovation, and project management, the Engineering department in Puurs is building the site’s future.
• The Process Automation team within Engineering actively works on automating and integrating systems and data flows.
• Thanks to our expertise and use of modern technologies, we can offer robust solutions in equipment and utilities automation, industrial application development and integration, and the required infrastructure.
• At the same time, we provide 24/7 support for all these systems in production
Life sciences
Requirements :
• Industrial, civil, or Bio-engineer with a strong interest in software development and technology.
• Good command of Dutch and English.
• Excellent proficiency in Dutch and English.
• Strong interpersonal skills.
• Excellent communication skills.
• Highly organized and accurate in your work.
• Experience or strong interest in project-based work, preferably on a production site.
• Possess sufficient patience and strategic insight to successfully complete site-wide projects.
• Able to find a good balance between compliance and efficiency in projects and processes.
• Customer-oriented and willing to go the extra mile to tailor processes to the needs of different clients.
• Proficient in Microsoft Office
Europe, Belgium, Flanders, Antwerp
5 to 10 years