Automation Engineer

Orise; Lewis Center (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Orise is looking for an automation engineer to support the design and integration of automated packaging lines in Lewis Center, Ohio. The successful candidate will work with ASRS and AGV systems, ensuring compliance with GxP regulations and enhancing operational efficiency.

Ideal applicants hold a Bachelor’s or Master’s degree in a related engineering field, have experience in regulated environments, and are skilled in problem-solving and robotics.

Qualifications

• Experience in GxP-regulated environments with understanding of regulations.
• Firsthand experience with industrial automation and integrated systems.
• Robotics experience preferred; familiarity with Industry 4.0 is a plus.

Responsibilities

• Support design and operation of automated packaging lines.
• Lead compliance documentation for automation systems.
• Collaborate with QA and IT/OT teams for GxP compliance.

Skills

Automation engineering

GxP compliance

Robotics

Industrial networks

Problem solving

Education

Bachelor’s or Master’s degree in Mechanical, Electrical, Automation Engineering

Tools

PLC systems

HMI/SCADA platforms

Automation software

Job description

Your Responsibilities

• Support the design, logistics, integration, and operation of automated packaging lines interfacing with the Automated Warehouse, including Automated Storage and Retrieval Systems (ASRS) and Automated Guided Vehicles (AGVs).
• Support the creation of equipment and systems specifications based on material, compliance and system operator requirements. Ensure all automation systems meet CGMP, 21 CFR Part 11 and FDA requirements
• Lead ASRS, AGVs and Automated Warehouse Compliance documentation
• Ensure ASRS/AGV design and operation meet all safety, quality, and regulatory compliance requirements.
• Support commissioning, qualification, validation, and operation of new AOH automated packaging lines.
• Lead and support the development, testing, implementation, validation, and operation of critical automation and software systems.
• Support Commissioning, Qualification, and Validation (CQV) activities for packaging, ASRS, and AGV systems.
• Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance.
• Ensure commissioning and qualification activities align with project requirements, milestones, and schedule commitments.
• Apply engineering principles and practices across automation, controls, robotics, and integrated systems.
• Demonstrate a strong understanding of OT/IT convergence, industrial networks, and system integration.
• Support and review machine controls design, including PLCs and HMI/SCADA platforms such as Allen- Bradley, Siemens, RSView, PanelView, and equivalent systems.
• Support site computer systems validation (CSV) activities and data integrity requirements.
• Work closely with ASRS and AGV vendors/consultants, ensuring contracts, technical specifications, and deliverables meet the customer’s requirements.
• Collaborate with users, peers, and management to ensure appropriate standardization and alignment.
• Demonstrate the ability to lead cross-functional initiatives and encourage critical, creative problem solving.
• Effectively lead and influence teams, achieving both technical outcomes and strong collaboration.

Your Profile

• Bachelor’s or Master’s degree in Mechanical, Electrical, Automation Engineering or related discipline
• Experience working in an operational GxP-regulated environment with a strong understanding of applicable regulations and standards
• Firsthand experience implementing industrial automation and integrated automation systems
• Experience with robotics (ASRS and AGV experience strongly preferred)
• Familiarity with Industry 4.0, IIoT, and digital manufacturing technologies
• Direct experience working in regulated environments (GMP, OSHA, EPA)
• Fluent in English with effective communication skill
• Willing to travel to manufacturing/customer sites when required.