Computerized Systems & Equipment Specialist.

What will you be doing?

You will work on the implementation, validation, and management of analytical equipment and computerized systems. Your responsibilities will include:

• Implementing current and future Annex 11 and Chapter 4 requirements;
• Validating computerized systems, hybrid systems, and Excel applications;
• Drafting and executing PQ protocols;
• Setting up and reviewing user access rights, audit trails, and other system controls;
• Conducting periodic reviews and assessing changes and software updates;
• Documenting and improving systems, data flows, and work processes;
• Supporting the full equipment lifecycle, including qualification, maintenance, calibration, changes, and decommissioning;
• Investigating and resolving recurring equipment and system issues;
• Drafting and improving procedures, work instructions, and user documentation.

You will work closely with Operations, Quality Assurance, Technical Operations, IT, process owners, system owners, and users.

What are we looking for?

You have a strong technical interest in laboratory software, computerized systems, and analytical equipment and you want to understand not just how a system works, but specifically how it can be set up to be reliable, manageable, and demonstrably GMP-compliant.

You possess:

• A Bachelor’s degree (HBO) or equivalent level of professional ability in a relevant technical, laboratory, or scientific field;
• Experience with analytical equipment, laboratory software, or digital laboratory processes;
• Affinity with validation, computerized systems, Excel validation, hybrid systems, and data integrity;
• Knowledge of GMP or the motivation to further develop this knowledge;
• An accurate, systematic, and practical way of working;
• The ability to independently carry out improvements from development to demonstrable completion in a project-based manner.

Experience with validation, equipment qualification, audit trails, user rights, data integrity, Microsoft SharePoint, Microsoft Power Automate, or laboratory information systems is a plus.

What makes this position interesting?

You will play an important role in the further digitalization and professionalization of Brightlabs and work at the intersection of laboratory, engineering, quality, and IT.

You will be involved with both existing equipment and systems as well as new solutions, and you will have the freedom to not only devise improvements but also actually implement them.

The position is part of the Operational Excellence & Equipment Lifecycle Management unit and reports to the Group Lead Operational Excellence & Equipment Lifecycle Management.

Interested?

Do you get energized by analytical equipment, computerized systems, validation, data integrity, and actually realizing improvements? Then we warmly invite you to apply.

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