The Automation Engineer works within the Engineering team to commission, qualify, maintain and improve the Equipment Automation systems in the Biologics facility.
You will work closely with Operations, IT, Engineering, Validation, QA and external Vendors to manage the lifecycle of the automated Control Systems and support engineering Projects in a regulated environment.
- Responsible for design, development, and testing of process automation systems such as Siemens WinCC, Step7, iFix, Intouch, Rockwell PLCs, etc.
- Responsible for integration of Control systems to the IT networks and Services, for example Domain Controllers, File/Print Servers etc.
- Responsible for providing support to manufacturing data historian systems such as OSI PI.
- Apply engineering principles and technical expertise in supporting project execution and operational support activities.
- Provide automation improvements based on cGMP’s related to the operation, validation, and maintenance of Control Systems.
- Support project execution, operational startup and handover of automation and target equipment systems to end-users.
- Support commissioning and qualification activities as required.
- Follow applicable standard operating procedures while working with qualified systems.
- Assist departmental objectives by proactively identifying continuous improvement opportunities and developing strategic roadmaps.
- Support Manufacturing Operations including change management for systems issue resolution and process improvement.
- Participate or lead quality or safety investigations and implement any automation solutions resultant from these investigations.
- Automation representative in capital projects involving facilities, utilities, equipment and develop, revise and review Specifications, Test Protocols and SOPs as needed.
- Audit and update existing system documentation and procedures.
- Ensure periodic preventive maintenance tasks on automation systems are documented, scheduled and carried out.
- A relevant third level qualification in a Mechatronics/IT/Software/ Electrical Engineering or equivalent technical degree with 3 years + relevant experience in Control Systems, Siemens etc., preferably in Pharmaceuticals/Life Sciences.
Technical Skills and Experience
- Proven track record in the Pharma/Medical Device environment. Clear understanding of working within a regulated environment.
- Practical working knowledge of a manufacturing environment.
- Knowledge of Pharma/Medical Device Data Integrity requirements.
- Experience with PLC programming in ladder logic and instructional texts, and HMI screen development and management required.
- Experience with commissioning and qualification, and computerised systems validation required.
- Detailed technical understanding of manufacturing systems, computer software and IT systems support.
- Experience with communication protocols such as ProfiNet, Profibus, Modbus, BACnet, etc. preferred.
- Experience of interfacing/configuring data historians such as OSI PI preferred.
- Experience administering Windows Server Operating Systems and related components preferred.
- Experience working in biologics production environment preferred.
Experience in Vision systems & Robotics an advantage.