Senior Automation Engineer

Senior Automation Engineer – Biopharma Manufacturing

About the Facility:
This state-of-the-art aseptic drug product operations site specialises in secondary manufacturing activities including formulation, vial/syringe filling, lyophilisation, inspection, and packaging. The facility supports a global supply network, maintaining high standards of quality, safety, and innovation to ensure continuous delivery of life-changing medicines to patients worldwide.

About the Role:
The Senior Automation Engineer will join the Plant Automation Team, supporting drug product manufacturing operations by maintaining and optimising automation systems within a GMP-regulated environment. This position acts as a System Owner for critical automation assets, driving reliability, lifecycle management, troubleshooting, and continuous improvement initiatives across multiple automation platforms.

Key Responsibilities

System Ownership & Reliability

• Serve as System Owner for automation systems, ensuring compliant lifecycle management, maintenance, and validation.

• Manage Change Controls, Deviations, and CAPAs related to automation systems.

• Maintain system documentation, configuration control, and software versioning in accordance with GMP standards.

Support & Troubleshooting

• Provide technical support to operations and engineering teams during production, shutdowns, and technology transfers.

• Lead or support incident investigations and root cause analyses for automation and control system issues.

Continuous Improvement & Innovation

• Implement corrective and preventive actions (CAPAs), including software updates, documentation revisions, and SOP improvements.

• Evaluate existing automation designs and recommend enhancements aligned with emerging technologies and regulatory expectations.

• Support digitalisation and Industry 4.0 initiatives, including data integration, advanced analytics, and automation optimisation.

Project & Technology Integration

• Support new product introductions and technology transfers by performing automation assessments, implementing control system modifications, and supporting engineering batches.

• Collaborate with cross-functional teams, stakeholders, and external vendors to deliver projects effectively and on schedule.

Safety & Compliance

• Promote a culture of safety, quality, and compliance across all automation-related activities.

• Ensure full adherence to EHS, GMP, and data integrity policies at all times.

Qualifications & Experience

• Bachelor’s Degree in Automation Engineering, Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related discipline.

• Minimum 5 years’ experience in an operations or manufacturing environment within the life sciences or process industry.

• Strong background in automation design, installation, validation, lifecycle management, testing, and programming.

• Experience with one or more of the following is advantageous:

  • Biopharmaceutical formulation or vial/syringe filling systems

  • Inspection and packaging automation

  • Siemens and Rockwell PLC/HMI platforms

  • SCADA systems such as iFix, InTouch, Zenon, or Rockwell FTView

  • Fieldbus systems: ControlNet, DeviceNet, Profibus, Profinet, AS-i, BACnet

• Knowledge of GAMP 5, ANSI/ISA-S88/S95, 21 CFR Part 11, and Annex 11 standards.

• Familiarity with network architecture, including TCP/IP and firewall management.

• Self-motivated, organised, and able to manage multiple priorities in a fast-paced environment.

• Excellent communication, technical writing, and stakeholder management skills.

• Team-oriented with a collaborative mindset and a commitment to operational excellence.

• Willingness to travel occasionally for training or vendor support.

Senior Automation Engineer – Biopharma Manufacturing

About the Facility:
This state-of-the-art aseptic drug product operations site specialises in secondary manufacturing activities including formulation, vial/syringe filling, lyophilisation, inspection, and packaging. The facility supports a global supply network, maintaining high standards of quality, safety, and innovation to ensure continuous delivery of life-changing medicines to patients worldwide.

About the Role:
The Senior Automation Engineer will join the Plant Automation Team, supporting drug product manufacturing operations by maintaining and optimising automation systems within a GMP-regulated environment. This position acts as a System Owner for critical automation assets, driving reliability, lifecycle management, troubleshooting, and continuous improvement initiatives across multiple automation platforms.

Key Responsibilities

System Ownership & Reliability

• Serve as System Owner for automation systems, ensuring compliant lifecycle management, maintenance, and validation.

• Manage Change Controls, Deviations, and CAPAs related to automation systems.

• Maintain system documentation, configuration control, and software versioning in accordance with GMP standards.

Support & Troubleshooting

• Provide technical support to operations and engineering teams during production, shutdowns, and technology transfers.

• Lead or support incident investigations and root cause analyses for automation and control system issues.

Continuous Improvement & Innovation

• Implement corrective and preventive actions (CAPAs), including software updates, documentation revisions, and SOP improvements.

• Evaluate existing automation designs and recommend enhancements aligned with emerging technologies and regulatory expectations.

• Support digitalisation and Industry 4.0 initiatives, including data integration, advanced analytics, and automation optimisation.

Project & Technology Integration

• Support new product introductions and technology transfers by performing automation assessments, implementing control system modifications, and supporting engineering batches.

• Collaborate with cross-functional teams, stakeholders, and external vendors to deliver projects effectively and on schedule.

Safety & Compliance

• Promote a culture of safety, quality, and compliance across all automation-related activities.

• Ensure full adherence to EHS, GMP, and data integrity policies at all times.

Qualifications & Experience

• Bachelor’s Degree in Automation Engineering, Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related discipline.

• Minimum 5 years’ experience in an operations or manufacturing environment within the life sciences or process industry.

• Strong background in automation design, installation, validation, lifecycle management, testing, and programming.

• Experience with one or more of the following is advantageous:

  • Biopharmaceutical formulation or vial/syringe filling systems

  • Inspection and packaging automation

  • Siemens and Rockwell PLC/HMI platforms

  • SCADA systems such as iFix, InTouch, Zenon, or Rockwell FTView

  • Fieldbus systems: ControlNet, DeviceNet, Profibus, Profinet, AS-i, BACnet

• Knowledge of GAMP 5, ANSI/ISA-S88/S95, 21 CFR Part 11, and Annex 11 standards.

• Familiarity with network architecture, including TCP/IP and firewall management.

• Self-motivated, organised, and able to manage multiple priorities in a fast-paced environment.

• Excellent communication, technical writing, and stakeholder management skills.

• Team-oriented with a collaborative mindset and a commitment to operational excellence.

• Willingness to travel occasionally for training or vendor support.