Senior Automation Engineer – Biopharma Manufacturing
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.
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.
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 i Fix, In Touch, Zenon, or Rockwell FTView
Fieldbus systems: Control Net, Device Net, 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.
