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Stillingsbeskrivelse
Automation & BMS/EMS Engineer
We are seeking an experienced and detail-oriented Automation and BMS/EMS Engineer to join our A&D team. In this role, you will maintain, program, and optimize critical control systems and validated environmental monitoring platforms within our regulated pharmaceutical production facility.
Key Responsibilities
- System Programming & Maintenance: Program, configure, and troubleshoot Siemens and Rockwell PLCs and HMIs on manufacturing equipment. Optimize automated processes to improve manufacturing efficiency and reduce downtime.
- BMS & FMS Administration: Operate, maintain, and configure Honeywell Enterprise Buildings Integrator (EBI) for facility environmental control. Oversee the validated Facility Monitoring System (FMS) to ensure continuous, accurate tracking of critical production parameters.
- Pharma Compliance & Quality Assurance: Ensure all automation engineering activities, software changes, and data storage align with GxP, GAMP5, and 21 CFR Part 11 regulations. Maintain strict data integrity protocols.
- System Validation: Author, review, and execute Installation Qualification and Operational Qualification (IQ/OQ) protocols for software, hardware, and FMS sensor upgrades. Manage calibration schedules and technical documentation.
- Cross-Functional Collaboration: Act as the technical point of contact for local vendors, internal quality teams, and international corporate stakeholders. Report and document system deviations, root-cause analyses, and CAPAs.
Krav
- You must have 5-7 years of engineering experience within a validated pharmaceutical, biotech, or medical device manufacturing plant.
- You must possess advanced, hands-on knowledge of Siemens (TIA Portal/Step 7) and Rockwell Automation (Studio 5000/FactoryTalk) platforms.
- You must have direct experience administering Honeywell EBI and managing validated Facility Monitoring Systems (FMS).
- You must have a thorough understanding of cleanroom classifications, data integrity principles, and automated system validation.
- You must have native or professional fluency in Norwegian (B2/C1 minimum) and professional working proficiency in English.
Ferdigheter
PLC Programming (Siemens/Rockwell)BMS/EMS Administration (Honeywell EBI)GxP/GAMP5 ComplianceSystem Validation (IQ/OQ)Data Integrity ProtocolsRoot-cause analysisNorwegian and English fluency
Erfaring
senior