Automation Engineer IV

oxfordbiom•Durham, NC

87d

About The Position

At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We’re currently recruiting for a Automation Engineer III to join our Manufacturing team. In this role, you will support cGMP manufacturing by working with process equipment, control systems, and instrumentation throughout all project phases, playing a key part in advancing our mission and making a real difference.

Requirements

Requires a BS/MS in Engineering or related field.
Must have 5+ years of experience working in a biotechnology company, with focus on cross functional support for cGMP manufacturing.
5+ years of experience in the execution of the automation discipline in a regulated manufacturing environment.
Strong understanding of GMPs and good engineering practice (GEP), including ISA S88, GAMP, ASTM E2500, ISPE guidance, etc.
Experience with HMI/SCADA packages such as: Rockwell RSView, FactoryTalk.
Experience with OSI PI.
Experience with PLCs such as: Rockwell, Siemens.
Experience owning SOPs, deviations, change controls, and CAPAs to support operations.

Nice To Haves

Experience in plant start up, equipment commissioning, and qualification is a plus.
Experience with recipe design and qualification for bioreactors or chromatography skids is a plus.

Responsibilities

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 sites 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.