System Owner Engineer Breda • Panda International

System Owner Engineer | Biopharmaceutical Manufacturing

About the Role

Responsible for the full lifecycle, compliance, and performance of critical utility and facility systems in a GMP-regulated environment. Act as system SME supporting operations, maintenance, and engineering projects.

Key Responsibilities

Life Cycle Management

• Provide SME input during conceptual/detailed design.
• Approve design documents and commissioning protocols.
• Ensure new systems meet safety, compliance, and reliability standards.

Operations & Maintenance

• Ensure systems operate per standards, OEM guidance, and regulations.
• Develop/approve maintenance plans and manage performance metrics.
• Drive reliability and continuous improvement initiatives.

Modifications & Retirement

• Assess system upgrades, obsolescence, and support change controls.
• Lead decommissioning activities with QA/Compliance.

Asset Management

• Maintain asset records in CMMS (Maximo/SAP).
• Manage lifecycle cost data, criticality assessments, and replacement strategies.
• Define spare parts strategies and manage obsolescence risks.

Compliance & Documentation

• Maintain validated state and inspection readiness.
• Own system documentation (SOPs, risk assessments, periodic reviews).
• Manage deviations, CAPAs, change requests, and compliance reporting.
• Support internal/external audits.

Project Support

• Act as SME in capital/OPEX projects.
• Support FAT/SAT, design reviews, punch lists, and system handover.
• Validate operational impact and capacity of proposed changes.

Decision-Making Authority

• Approve SOPs, PM plans, operational changes.
• Accept/reject new systems and project handovers.
• Prioritize maintenance, upgrades, and downtime.
• Initiate/coordinate change controls, deviations, CAPAs.

Collaboration

• Internal: QA, EHS, Reliability, Manufacturing, Validation, Maintenance, Projects, IT/OT.
• External: Vendors, OEMs, contractors, utility providers, inspectors.

Required Skills & Experience

• Bachelor’s or Master’s degree in Engineering (Electrical, Industrial, Mechanical preferred).
• Experience in GMP-regulated pharma/biotech/food environments.
• Familiarity with utility systems: HVAC, compressed air, BMS, refrigeration, fire safety.
• Knowledge of applicable legislation and compliance frameworks.
• Strong analytical, documentation, and stakeholder management skills.
• Excellent communicator in English and Dutch.
• NEN3140 (Installation Responsible) or willingness to obtain.

Additional Info

Department: Engineering / Facilities & Utilities

Location: Breda

Start Date: ASAP

Interested? Apply directly or contact Miguel Gomes at via de button "Solliciteer nu" op deze pagina. or call +31 20 20 44 502 for more information.