Mix Talent is partnering with an established biopharmaceutical organization to identify an Automation Engineer to support its advanced development and manufacturing operations in central Ohio.
This role is part of a multidisciplinary engineering team responsible for the reliability, performance, and continuous improvement of automation and process control systems across a highly regulated manufacturing environment. The engineer will contribute to automation system design and configuration, testing and implementation, troubleshooting, documentation, and ongoing operational support.
The position offers the opportunity to work across a range of process and facility systems, supporting activities from process development through manufacturing. The successful candidate will collaborate with engineering, manufacturing, maintenance, validation, quality, and IT teams to implement compliant, reliable automation solutions and support new products, technologies, and capital projects.
Key Responsibilities
- Automation Engineering: Develop, configure, maintain, and troubleshoot automation and process control systems, including PLCs, Human-Machine Interfaces (HMIs), SCADA platforms, Building Management Systems (BMS), and related control technologies.
- System Configuration & Testing: Implement automation system modifications, develop and execute test protocols, maintain system configurations, and ensure changes are appropriately verified and documented.
- Technical Documentation: Develop, review, and maintain engineering and automation lifecycle documentation, including user requirements, functional specifications, design documentation, and qualification deliverables.
- Quality & Compliance: Initiate and support change controls, deviation investigations, and Corrective and Preventive Actions (CAPAs). Ensure automation activities meet applicable cGMP requirements, data integrity expectations, and site quality standards.
- Manufacturing & Facility Support: Provide automation engineering support for process equipment, facility utilities, environmental and building systems, and manufacturing operations. Relevant applications may include bioreactors, upstream and downstream processing, harvest, media preparation, laboratory operations, and warehouse systems.
- Operational Troubleshooting: Investigate and resolve automation and controls issues affecting manufacturing, facilities, and validation activities. Participate in an on-call rotation and provide operational support as required.
- Computerized Systems Validation: Partner with Quality and Validation teams to support computerized systems validation in a GxP environment, including data integrity assessments and compliance with applicable regulatory and industry standards.
- New Product & Technology Introductions: Support new product introductions, equipment upgrades, and emerging technologies through automation assessments, system configuration, engineering execution, and qualification activities.
- Capital Projects: Contribute to projects throughout the engineering lifecycle, including concept development, scope definition, cost estimates, detailed design, implementation, testing, and validation.
- Systems Integration & Infrastructure: Collaborate with IT and digital technology teams to support process control network architecture, system integration, cybersecurity, network compatibility, and infrastructure reliability.
- Cross-Functional Collaboration: Work closely with manufacturing, maintenance, engineering, quality, validation, and external service providers to coordinate technical activities and ensure work is executed safely, efficiently, and compliantly.
- Standards & Continuous Improvement: Develop and apply standardized control strategies, support automation system lifecycle management, coordinate preventative and corrective maintenance, and help maintain critical system support and spare parts coverage.
- Communication & Training: Lead or contribute to technical meetings and projects, communicate effectively with stakeholders at multiple organizational levels, and provide training and technical guidance as needed.
- Support automation systems and engineering activities across multiple facilities in the central Ohio region.
- Perform other related duties as business needs require.
Required Qualifications
- Bachelor's degree in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or a related technical discipline.
- At least 3 years of relevant experience in automation engineering, instrumentation and controls, process control systems, or a closely related technical field.
- Working knowledge of the design, programming, installation, troubleshooting, and lifecycle management of manufacturing automation systems and field instrumentation.
- Experience supporting process control systems and associated infrastructure, including process control network design, network segmentation, virtualized environments, and system integration.
- Familiarity with industrial communication protocols and integration technologies, including OPC and DeviceNet.
- Working knowledge of user and access lifecycle management, including account creation, modification, deactivation, and local machine directory administration.
- Familiarity with BACnet communication protocols.
- Experience contributing to capital projects, including conceptual design, scope development, cost estimation, detailed engineering, technical documentation, validation, and implementation.
- Strong technical writing, documentation, problem-solving, and troubleshooting skills.
- Ability to manage multiple priorities, collaborate across functional teams, and communicate technical information clearly to both technical and nontechnical stakeholders.
- Ability to support on-call operational needs and work across multiple locations in central Ohio.
Preferred Qualifications
- Experience supporting automation and process control systems in a GMP-regulated biopharmaceutical or pharmaceutical development and manufacturing environment.
- Direct experience with systems such as BMS and environmental monitoring systems (EMS), PLCs, variable frequency drives (VFDs), bioreactors, and upstream or downstream process equipment.
- Experience integrating automation platforms and original equipment manufacturer (OEM) control systems.
- Familiarity with Ignition or similar platforms for automation visualization, dashboards, data visualization, and configurable reporting.
- Understanding of computerized systems validation, data integrity, and regulated system lifecycle documentation.
- Knowledge of applicable regulatory and industry standards, including 21 CFR Part 11, GAMP 5, ISA-88 (S88), and ISA-95.
- Experience applying Good Manufacturing Practices (GMP) and Good Automated Manufacturing Practice (GAMP) principles to automation design, implementation, and lifecycle management.