System Owner Engineer

Opdrachtgever

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world.

Bachelor’s or Master’s degree in Engineering (preferred Electrical, Industrial, Mechanical).
Experience in GMP-regulated (pharmaceutical, biotech or food environment).
NEN3140 (installation responsible) Willing to obtain.
Knowledge applicable legislation.
Familiarity with utility systems (HVAC? compressed air, BMS, refrigeration, fire safety).
Strong analytical, documentation, and stakeholder management skills.
Strong communicator in English and Dutch.

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.
Develop and approve maintenance plans.
Manage performance metrics and ensure system reliability.
Participate in change control processes.
Lead decommissioning planning and execution in coordination with QA/Compliance.
Maintain spare part strategies and obsolescence risk management.
Ensure the system operates in a validated state and is inspection-ready at all times.
Lead periodic review activities and support audits and inspections.
Monitor compliance KPIs and address deviations, CAPAs, and change requests.
Act as system SME in capital and OPEX projects.
Support Factory and Site Acceptance Testing (FAT/SAT), design reviews, and punch-list resolution.
Accept or reject new systems, modifications, or handovers from projects.
Prioritize maintenance, upgrades, and downtime within scope.
Initiate and coordinate change controls, deviations, and CAPAs relevant to the system.