Automation Engineer IV

Role Overview

• 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.

Requirements

• Requires a BS/MS in Engineering or related field
• Must have 8+ years of experience working in a biotechnology company, with focus on cross functional support for cGMP manufacturing
• 8+ 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.
• This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

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
• A company that lives its values: Responsible, Responsive, Resilient, Respect