OXB · 15 hours ago
Automation Engineer IV
Durham, NC
Full-time
Onsite
Senior Level
5+ years expOXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. 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.
BiotechnologyGeneticsTherapeutics
No H1B
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
Qualification
Required
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
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
Benefits
Competitive total reward packages
Wellbeing programs that support your mental and physical health
Career development opportunities to help you grow and thrive
Supportive, inclusive, and collaborative culture
State-of-the-art labs and manufacturing facilities
Company
OXB
OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life changing therapies to patients around the world.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$217.05MKey Investors
Oaktree Capital ManagementSerum Institute of India Pvt. Ltd.
2025-08-01Post Ipo Debt· $60M
2021-09-22Post Ipo Equity· $68.08M
2019-05-01Post Ipo Equity· $69.83M
Leadership Team
Emily Yu
Oxford BioMedica CMO
Recent News
2026-01-16
2026-01-16
2026-01-16
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