This role is suited for an experienced Automation and BMS/EMS Engineer with strong expertise in PLC programming, building automation systems, and environmental monitoring within a regulated pharmaceutical or biotech manufacturing environment. The position focuses on maintaining and optimizing Siemens/Rockwell automation systems, Honeywell EBI BMS, and validated monitoring platforms while ensuring compliance with GxP, GAMP5, data integrity, and regulatory requirements.

Role Overview

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. The ideal candidate possesses deep technical expertise in PLCs, building automation, and data integrity compliance, combined with the ability to collaborate fluently in Norwegian.

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 (temperature, humidity, differential pressure, particles).
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 for all monitored environmental data.
System Validation
- Authors, reviews, and executes Installation Qualification and Operational Qualification (IQ/OQ) protocols for software, hardware, and FMS sensor upgrades.
- Manage calibration schedules and technical documentation for critical monitoring instruments.
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 fluently in both Norwegian and English.

Technical Requirements

PLC/HMI Experience: Advanced, hands-on knowledge of Siemens (TIA Portal/Step 7) and Rockwell Automation (Studio 5000/FactoryTalk) platforms.
BMS/EMS Expertise: Direct experience administering Honeywell EBI and managing validated Facility Monitoring Systems (FMS).
Industry Experience: Minimum of 5-7 years of engineering experience working inside a validated pharmaceutical, biotech, or medical device manufacturing plant.
Regulatory Knowledge: Thorough understanding of cleanroom classifications, data integrity principles, and automated system validation.

Language & Soft Skills

Norwegian: Native or professional fluency (B2/C1 minimum) required for local regulatory communication and vendor management.
English: Professional working proficiency required for corporate documentation and global team alignment.
Problem Solving: Strong analytical mindset with a proven ability to diagnose complex runtime errors under tight production schedules.

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