Engineer (34789)
TR/079894
Posted: 14/11/2025
- €26.28 - €27.66 per hour
- Netherlands, Provincie Noord-Brabant, Breda
- Contract
Orion Group Life Sciences are looking for an Engineer (System Owner Engineer) for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with high possibility of extension. This is a fully onsite position.
Main Responsibilities of the role
#opportunity #multinational #pharmaceutical #biotechnology #GMP #engineer #systemsowner #lifecyclemanagement #assetmanagement #compliance #capitalprojects #OPEXprojects #FAT #SAT
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Main Responsibilities of the role
- 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 our client’s 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, etc.
- Lead periodic review activities and support audits and inspections.
- Monitor compliance KPIs and address deviations, CAPAs, and change requests.
- Submit or coordinate required internal and external compliance reports.
- Support for Projects (Construction & Engineering):
- Act as system SME in capital and OPEX projects.
- Participate in project steering teams and provide system-specific requirements.
- Support Factory and Site Acceptance Testing (FAT/SAT), design reviews, and punch-list resolution.
- Coordinate system handover and ensure readiness for use.
- Validate capacity impact and operational sustainability of proposed changes.
- Decision-Making Powers:
- Approve system-specific SOPs, PM plans, and operational changes.
- 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.
- Interfaces & Collaboration:
- Internal: QA, EHS, Reliability, Manufacturing, Validation, Maintenance, Capital Projects, IT/OT.
- External: Vendors, OEMs, contractors, utility providers, and regulatory inspectors (when required).
- 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.
#opportunity #multinational #pharmaceutical #biotechnology #GMP #engineer #systemsowner #lifecyclemanagement #assetmanagement #compliance #capitalprojects #OPEXprojects #FAT #SAT
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
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