- Planning and execution of Automation systems being implemented on site
- 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, and 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 24x7 manufacturing cGMP operation.
- 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 in plant start-up, equipment commissioning and qualification is a plus
- A passion for addressing the critical unmet medical needs of patients
- Self-directed individual who can work with limited direction in a fast-paced, goal-oriented environment
- 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
- BS/MS in Engineering or related field
- Have 5+ years of experience working in a biotechnology company
- 5+ years of experience in the execution of the automation discipline in a regulated manufacturing environment
- Willingness to embrace and demonstrate the principles of the Resilience phenotype: Resilience + Grit, Velocity, Service-orientation, EQ + IQ, Builder Mentality, Quality + Rigor, Ownership
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Automation Engineer III - Durham, United States - Resilience Corp.
Description
A career at Resilience is more than just a job - it's an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit
Position Summary
As an Automation Engineer III, you will have knowledge of process manufacturing, biomanufacturing process equipment, data historians, OPC, PLCs and associated coding methods, field instrumentation, control system installation and implementation expertise in all of the following project phases: Requirement's documentation, detailed design generation, implementation, system integration, testing and on-site startup.
Job Responsibilities
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $85, $118,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.
