Senior Automation Engineer
Bluebird Bio, Durham, North Carolina, United States
integrated product platforms with broad therapeutic potential
Join bluebird bio’s enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approaches. We are seeking a Process Automation leader to join our new manufacturing facility, bluebird Research Triangle (bRT), in North Carolina. The 125,000 square foot facility will produce lentiviral vector for our gene and cell therapies, including treatments for multiple myeloma, transfusion-dependent b-thalassemia and sickle cell disease. The site is large enough to accommodate significant potential future expansion. This role will report to the Director of Site Engineering.
The ideal candidate must have knowledge of process manufacturing, field instrumentation, control system installation and implementation expertise in all of the following project phases: Requirements documentation, detailed design generation, implementation, system integration, testing and on-site startup.
- Planning and execution of Automation systems being implemented at bRT (bluebird Research Triangle): Durham, NC facility.
- Execute process and building automation system strategic plans for bRT: Durham, NC.
- Provide technical support for automation projects, including automation system design, control system hardware, equipment design, control panel design, 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.
- Support automation issue identification 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.
- Requires a BS/MS in Engineering or related field
- Must have 5+ years of experience working in biotechnology company
- Strong understanding of GMPs and good engineering practice (GEP), including ISA S88, GAMP, ASTM E2500, ISPE guidance, etc.
- 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 24x7 manufacturing cGMP operation.
- Experience with HMI/SCADA packages such as: Rockwell RSView, FactoryTalk
- Experience with OSI PI.
- Experience with PLCs such as: Rockwell, Siemens
- Experience in plant start up, equipment commissioning and qualification is a plus.
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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