Automation Engineer

Mix Talent; Columbus (OH); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Mixtalent is seeking an Automation Engineer to support Cell and Gene Therapy development and manufacturing facilities in Dublin and Columbus, Ohio. You will implement automation changes, update design documents, execute testing, troubleshoot events, and participate in on-call support to deliver automated solutions for process development, upstream/downstream, facilities/utilities, and lab operations.

The role involves working with HMIs, PLCs, BMS, and SCADA, developing documentation, and

Formación

• Bachelor's degree in electrical, chemical, or mechanical engineering.
• Minimum of 3 years of Automation, Instrumentation & Controls, or other relevant technical experience.
• Experience with Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation and ability to perform troubleshooting activities, understand system Integration using OPC, and DeviceNet technologies.

Responsabilidades

• Develop and maintain process control automation solutions (HMI, PLCs, BMS, SCADA).
• Performs automation activities: code configuration, document development, and test execution.
• Develop and complete Deviation Reports, CAPAs and Change Controls within the Quality Management System.
• Collaborate with Manufacturing, Maintenance, and Validation teams.
• Conduct training and present information to team or stakeholders.
• Lead and support new product introductions by performing automation assessments and supporting qualification runs.
• Manage day-to-day operational support including 24x7 on-site/on-call, troubleshooting, maintenance, and spare parts management.
• Provide clear documentation and support computerized systems validation with QA; maintain data integrity per CFR.
• Work with DTS to ensure equipment compatibility with network protocols and security standards.
• Coordinate contracted service providers and establish coverage of critical systems.

Conocimientos

Automation

Instrumentation

Controls

Project leadership

Educación

Bachelor's degree in electrical, Chemical, or Mechanical Engineering

Herramientas

OPC

DeviceNet

BACnet

Descripción del empleo

The Automation Engineer is a member of the Facilities and Engineering (F&E) team and will provide support to the Cell and Gene Therapy (CG&T) development and manufacturing facilities located in Dublin and Columbus, Ohio. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. This role focuses on supporting the delivery of automated solutions to support Process Development, Downstream/Upstream process, Facilities/Utilities, Warehouse and areas including Lab, Media Preparation, Seed Culture, Small/Large Scale Bioreactors, and Harvest.

• Develop and maintain process control automation solutions Human Machine Interfaces (HMI), PLCs, Building Management Systems (BMS), and Supervisory Control and Data Acquisition systems (SCADA), as applicable.
• Performs Automation activities, such as code configuration, document development, and test execution within several process areas
• Responsible for developing and completing Deviation Reports, CAPAs and Change Controls as part of the Quality Management System in support of Site’s compliance readiness.
• Collaborate with other departments, such as Manufacturing, Maintenance, and Validation
• Conducts training and presents information to team or other stakeholders
• Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes and supporting engineering and process qualification runs as applicable.
• Manage Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Mfg. Operations, Validation, Automation System Administration, Preventative and corrective maintenance, and Automation System spare parts management
• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current CFR and Industry standards.
• Working as part of a focused multi-facility team, the Automation Engineer will ensure any modification, installation, preventative maintenance, operational support, or troubleshooting activity is properly completed and documented in compliance with engineering specifications and current Good Manufacturing Practice guidelines
• Work Closely with Digital & Technology Solutions (DTS) team to ensure equipment is compatible with network protocols and security standards
• This position requires the ability to lead projects, facilitate meetings, provide consistently, and professional communication throughout all levels of the organization
• Coordinate contracted service providers and ensure that work performed meets regulatory expectations
• Establish agreements, as requested, to ensure coverage of critical systems
• Position has responsibilities at multiple locations in central Ohio (Columbus and Dublin)
• Ability to clearly and concisely express thoughts in written procedures, protocols, and reports
• Other duties as assigned

What you bring to the team:

• Bachelor’s degree in electrical, Chemical, or Mechanical Engineering or other relevant field
• Minimum of 3 years of Automation, Instrumentation & Controls, or other relevant technical experience
• Understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
• Experience with Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation and ability to perform troubleshooting activities, understand system Integration using OPC, and DeviceNet technologies.
• Requires working knowledge of:
• Machine Local Directory Administration: manage local user accounts
• BACnet Communication protocols
• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, case development, detailed design, engineering and validation documentation and project implementation.

Preferred Qualifications:

• Direct knowledge of Automation design, experience in process control engineering and solving problems with GMP biopharmaceutical production facility equipment/systems such as Building Management Systems (BMS/EMS), harvest, bioreactors, PLCs, VFDs and integrating various OEM automation software, such as Ignition Dashboard, Data Visualization and User configurable dashboards and reports
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, S88, and ISA95 and ISPE GAMP-5.