Automation Engineer
Role Overview:
The Automation Engineer is a system owner within the Operations Technology (OT) sustaining team, responsible for the administration, maintenance, and continuous improvement of automation systems in a GMP-regulated biopharmaceutical environment. This includes support for manufacturing operations, new technology introduction, troubleshooting, and lifecycle management.
Key Responsibilities:
System Ownership & Site Support
- Administer and monitor automation systems (PLC, SCADA, PCS, BMS).
- Ensure compliance with GMP, EHS, and quality standards.
- Perform root cause analysis, lead investigations, and implement improvements.
- Conduct change control and lifecycle activities (backups, updates, periodic reviews).
Project Support
- Support hardware/software upgrades and system integration.
- Manage small/medium automation projects through full life cycle.
- Participate in commissioning and qualification activities.
- Lead continuous improvement initiatives.
Computerised System Lifecycle
- Disaster recovery, configuration, access management.
- Validate systems per CSV and GAMP standards.
- Optimize maintenance plans using FMEA and performance data.
Quality & Compliance
- Document deviations, complete CAPAs and quality records.
- Maintain compliance with 21 CFR Part 11, EU Annex 11, and site policies.
EHS Responsibilities
- Ensure contractor compliance, safe work environments, and timely reporting of incidents.
- Adhere to PPE and participate in EHS programs and training.
Qualifications & Experience:
Ideal Candidate:
- Degree in Automation, Electrical, Chemical, Computer Science, or Biotech Engineering.
- 5+ years' experience in biopharma manufacturing automation (API or Fill/Finish).
- Strong knowledge of PLC (Siemens, Allen Bradley), PCS7, SCADA, BMS, and batch systems.
- Experience with industrial networks (ControlNet, Profibus), OSIsoft PI, VersionDog, etc.
- Familiar with GAMP5, S88/S95, 21 CFR Part 11, and Annex 11.
- Demonstrated experience with technical writing, project execution, and regulatory audits.
Minimum Requirements:
- Bachelor's degree in relevant field.
- 2+ years hands-on automation experience in a cGMP environment.
- Experience in Siemens PLC/HMI, PCS7, SCADA, and network technologies (TCP/IP, AD).