System Engineer

As a System Owner Engineer, you will be the technical authority for critical utility systems, ensuring they operate safely, reliably, and in full compliance with GMP and regulatory standards. You’ll manage the entire lifecycle—from design and commissioning to operation, modification, and retirement, while driving continuous improvement and supporting key projects.Key ResponsibilitiesLife Cycle Management: Provide expertise during design phases, approve documentation, and ensure new systems meet operational, safety, and compliance standards.Operation & Maintenance: Ensure systems operate per standards and regulations, develop maintenance plans, and monitor reliability metrics.Modification & Retirement: Evaluate upgrade needs, manage change controls, and lead decommissioning activities with QA/Compliance.Asset Management: Maintain accurate asset records, manage lifecycle costs, and define criticality and spare part strategies.Compliance & Reporting: Keep systems validated and inspection-ready, maintain documentation, lead audits, and manage compliance KPIs and CAPAs.Project Support: Act as SME for projects, participate in design reviews, support FAT/SAT, and ensure smooth system handover.Decision-Making Authority: Approve SOPs and operational changes, accept or reject system modifications, and prioritize maintenance and upgrades.Interfaces & Collaboration: Collaborate with internal teams and external vendors, contractors, and regulatory inspectors to ensure system performance and compliance.Qualifications & SkillsBachelor’s or Master’s degree in Engineering (Electrical, Industrial, or Mechanical preferred).Experience in GMP-regulated environments (pharmaceutical, biotech, or food industry).NEN3140 (Installation Responsible) or willingness to obtain.Knowledge of applicable legislation and compliance requirements.Familiarity with utility systems (HVAC, compressed air, BMS, refrigeration, fire safety).Strong analytical and documentation skills.Excellent stakeholder management and communication skills in English and Dutch.