Digital Process Development Engineer – Manufacturing Automation & Data Integration - (JP16093)

3 Key Consulting•New Albany, OH

1d•Onsite

About The Position

3 Key Consulting is hiring a Digital Process Development Engineer for a consulting engagement with a leading global biopharmaceutical company. The role supports the development and implementation of digital tools for manufacturing and process development at a packaging facility in New Albany, Ohio. It combines programming and engineering problem-solving with direct support of Process Development activities on the manufacturing line in a regulated manufacturing environment. The engineer will work with Process Development, Operations, Quality, Automation, engineering, and technology specialists. They will participate in equipment and process characterization, engineering runs, troubleshooting, data collection, and line-based studies under the guidance of experienced Process Development staff. They will use practical knowledge of equipment, materials, and process behavior to develop useful, maintainable digital tools. The role takes defined engineering needs through requirements development, implementation, testing, documentation, and handover. The work includes automating verification activities; managing equipment settings, process parameters, and configuration data; integrating manufacturing data; improving access to technical information; connecting product and manufacturing information through its lifecycle; and supporting modeling, simulation, and AI-assisted tools with appropriate testing and human review. The position is onsite and requires flexibility to support first-, second-, or third-shift schedules as needed for continuous coverage of Process Development activities. The engagement is planned for at least one year, with likely extensions and/or conversion to permanent employment.

Requirements

Master’s degree; or bachelor’s degree and 2 years of experience; or associate degree and 6 years of experience; or high school diploma/GED and 8 years of experience.
Hands-on experience developing and supporting Python applications, SQL queries, APIs, and data-processing workflows to build and troubleshoot practical engineering tools.
Understanding of manufacturing equipment, process parameters, and automation concepts, and willingness to support characterization, engineering runs, and other Process Development activities on the manufacturing line.
Ability to translate engineering needs into clear requirements, investigate problems systematically, implement and test solutions, analyze data, and document results through cross-functional collaboration.
Flexibility and availability to support first-, second-, or third-shift schedules as needed for continuous, 24-hour Process Development coverage.
Ability to collaborate with engineering, automation, technology, Operations, and Quality partners.

Nice To Haves

Familiarity with PLC tags, industrial data connectivity, and manufacturing historians.
Experience with data platforms such as Databricks, cloud data services, dashboards, or visualization tools.
Familiarity with product lifecycle management, engineering configuration management, or requirements traceability.
Experience applying AI tools to technical information retrieval, workflow automation, or engineering analysis, with appropriate testing and human review.
Working knowledge of version control, debugging, software testing, and change management.
Experience in pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment.
Exposure to CAD, engineering simulation, or digital twin applications.
Internship experience is acceptable.

Responsibilities

Contribute to digital engineering projects and hands-on Process Development activities on manufacturing lines.
Support equipment and process characterization, engineering runs, and other Process Development studies under the guidance of experienced staff.
Assist with study planning, protocol preparation and execution, observation of line performance, process-data collection and analysis, troubleshooting, and documentation of results according to applicable site procedures.
Work with Operations, Quality, Automation, and engineering partners to investigate process issues and identify improvement opportunities.
Develop tools for automated verification, data comparison, and discrepancy identification in engineering and manufacturing information.
Build and maintain solutions for managing equipment settings, process parameters, and configuration data.
Read and interpret equipment data from PLCs, historians, and other manufacturing systems in collaboration with automation engineers.
Develop data-processing workflows, pipelines, dashboards, and reporting tools; investigate data-quality issues and communicate findings.
Gather user requirements and take defined engineering needs through implementation, debugging, testing, documentation, and handover.
Support digital product lifecycle management by organizing and connecting product, component, equipment, and process information.
Develop AI-assisted tools for technical information retrieval, data analysis, and engineering documentation, with appropriate testing and human review.
Support modeling and simulation activities through engineering data preparation and integration with technical specialists.
Maintain source traceability, version-controlled code, test results, operating instructions, and handover materials consistent with applicable site procedures.
Build practical knowledge of equipment, materials, and process behavior through direct participation in line activities and apply that knowledge to engineering tools.
Support first-, second-, or third-shift Process Development activities as needed to provide continuous coverage.