Oxford Biomedica

QA Automation Engineer

• Planning, execution, and monitoring of Automation systems utilized on site for cGMP manufacturing and facility utilities.
• Provide technical support for automation projects, including automation system design, control system hardware, equipment design, control panel design, alarm management, and instrumentation start-up and troubleshooting.
• Support development of technical standards, guidelines, and procedures in accordance with industry best practices.
• Support automation system design and integration, including hardware/software design specification development, user / functional requirement development, integration, and validation in conjunction with IT Computer Systems Validation & QA Validation leads.
• Develop P&IDs and loop descriptions for various processes, and/or equipment.
• Partner with automation system service providers, contract resources and Instrument/Electrical technicians ensuring safe, compliant maintenance and project execution.
• Maintain current contacts as needed for system support.
• Support automation issue identification, communication, and resolution, including all compliance aspects such as Deviation investigation, Change Control, Corrective and Preventative Action (CAPA).
• Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations, including being on-call for after-hours remote support.
• Support the design, configuration, administration and maintenance activities of the site's manufacturing computer and automation systems, including process control systems, building automation systems, manufacturing execution systems, and data historians.
• Ability to evaluate automation systems from a compliance perspective and ensure adherence to applicable standards (i.e. 21CFR Part 11, EU Annex 11).
• Troubleshooting experience, both hardware and software, at a manufacturing cGMP operation with flexibility to support operations on off hours.

Automation Engineer IV