System Owner Engineer
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50+ years experience - Deep subject-matter expertise - Global Life Sciences network Logo Talentmark ENNederlands (Nederland) language flag Nederlands (Nederland) language flag Welcome, make your choice We offer services for both clients and job seekers. Make your selection above so that we can offer you the right experience. System Owner Engineer - Engineering - Netherlands, Breda - November 17, 2025 - Fulltime - Wo - V-163297 - Competitive System Owner Engineer For a pharmaceutical client we are seeking a bi-lingual (Dutch & English) System Owner Engineer. Someone with familiarity with utility systems, for example HVAC, air, refrigeration, fire safety). Do you have experience within a GMP related industry, pharmaceutical, biotech or food? Please read further! Responsibilities: Life Cycle Management - Design Input & Commissioning - Provide subject matter expertise (SME) during conceptual and detailed design phases. - Approve design documents and commissioning protocols.
- Ensure new systems meet operational, safety, compliance, and reliability standards. Operation & Maintenance - Ensure systems are operated per Amgen standards, OEM recommendations and applicable regulations. - Develop and approve maintenance plans. - Manage performance metrics and ensure system reliability. Modification & Retirement - Evaluate system upgrade needs or obsolescence. - Participate in change control processes. - Lead decommissioning planning and execution in coordination with QA/Compliance. Asset Management - Maintain asset records in CMMS (e.g., Maximo, SAP). - Manage lifecycle cost data and recommend replacements or upgrades. - Define and ensure adherence to asset criticality assessments. - Maintain spare part strategies and obsolescence risk management. Compliance & Reporting - Ensure the system operates in a validated state and is inspection-ready at all times. - Maintain and approve system documentation: SOPs, risk assessments, ...