System Owner Engineer, Breda, Noord-Brabant

The Company
Our client is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions

Role Description
As a System Owner Engineer is responsible for the full lifecycle management of assigned technical systems within a GMP-regulated environment. This includes providing subject matter expertise during design and commissioning, ensuring reliable and compliant operation, managing maintenance and asset performance, leading change control and system upgrades, and maintaining inspection readiness.

Responsibilities

• Manage the complete lifecycle of systems, including design input, commissioning, and decommissioning. Approve design documents and ensure systems meet operational, safety, and compliance standards.
• Ensure systems are operated in accordance with company standards, OEM guidelines, and applicable regulations. Develop and oversee maintenance plans, monitor performance metrics, and ensure system reliability.
• Lead system modifications, evaluate upgrade requirements, participate in change control processes, and coordinate system retirements with QA and compliance teams.
• Maintain accurate asset records within the CMMS (such as Maximo or SAP), manage lifecycle costs, and develop strategies for spare parts and obsolescence mitigation.
• Ensure systems are inspection-ready, compliant, and in validated states. Maintain documentation, lead review activities, and support audits and inspections. Address deviations, CAPAs, and change requests proactively.
• Support construction and engineering projects by acting as the system subject matter expert, participating in project reviews, and coordinating testing and handover activities.

Requirements

• Bachelor’s or Master’s degree in Engineering (preferably Electrical, Industrial, or Mechanical).
• Prior experience in GMP-regulated environments (pharmaceutical, biotech, or food).
• Knowledge of applicable legislation and standards, with a willingness to obtain NEN3140 certification.
• Familiarity with utility systems like HVAC, compressed air, BMS, refrigeration, and fire safety.
• Strong analytical, documentation, and stakeholder management skills.
• Fluent in English and Dutch, with excellent communication skills.

Other Information
Apply to our vacancy for more information. looking forward to hearing from you.

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