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 m.gomes@panda-int.com or call +31 20 20 44 502 for more information.