System Owner Engineer

System Owner Engineer - GMP Environment

 

Job Description

A regulated manufacturing organisation is seeking an experienced System Owner Engineer to take ownership of assigned utility and technical systems within a GMP-regulated environment (pharmaceutical, biotech, or food). The role is responsible for full system life cycle management, including design input, commissioning, operation, maintenance, modification, and retirement, ensuring systems meet operational, safety, compliance, and reliability standards at all times.

In this role, you will act as the system Subject Matter Expert (SME), partnering closely with internal stakeholders including QA, EHS, Validation, Maintenance, Manufacturing, Engineering, Capital Projects, and IT/OT, as well as external vendors, OEMs, contractors, utility providers, and regulatory inspectors when required. You will support capital and OPEX projects, manage system documentation, and ensure systems remain in a validated and inspection-ready state. The position includes an on-call duty, typically once per month, consisting of 24/7 availability for seven consecutive days to support ongoing maintenance activities.

 

Essential Requirements

· Bachelor’s or Master’s degree in Engineering (Electrical, Industrial, or Mechanical preferred)

· Experience working in a GMP-regulated environment (pharmaceutical, biotech, or food)

· Knowledge of applicable legislation and regulatory requirements

· NEN3140 (installation responsible) certification or willingness to obtain

· Familiarity with utility systems such as HVAC, compressed air, BMS, refrigeration, and fire safety systems

· Strong analytical skills and a structured approach to documentation

· Strong stakeholder management and cross-functional collaboration skills

· Strong communication skills in English and Dutch

Preferred Requirements

· Experience acting as a System Owner or system SME within a regulated manufacturing environment

· Experience using CMMS systems such as Maximo or SAP

· Experience supporting audits, inspections, deviations, CAPAs, and change control processes

· Experience supporting capital projects, including FAT/SAT, design reviews, and system handover

· Experience managing asset lifecycle data, spare part strategies, and obsolescence risks

 

Practicalities

Start Date: ASAP/February

Location: Breda, NL

Contract Type: 1 year (extensions possible)

On-Call Duty: Once per month, 24/7 for 7 consecutive days

Scope: Full lifecycle ownership of assigned utility and technical systems

 

Interested? Send your CV to Miguel Gomes at m.gomes@panda-int.com or call +31 (0)20 2044 502 / +41 (0)44 5514 407 to discuss the opportunity.