Automation Engineer

ATS Automation•Orange Township, OH

8d•Onsite

About The Position

This role supports the design, logistics, integration, and operation of automated packaging lines that interface with the Automated Warehouse, including Automated Storage and Retrieval Systems (ASRS) and Automated Guided Vehicles (AGVs). The position requires ensuring all automation systems meet CGMP, 21 CFR Part 11, and FDA requirements, and involves leading ASRS, AGVs, and Automated Warehouse Compliance documentation. The engineer will ensure ASRS/AGV design and operation meet all safety, quality, and regulatory compliance requirements, and support commissioning, qualification, validation, and operation of new automated packaging lines. A key aspect of the role is leading and supporting the development, testing, implementation, validation, and operation of critical automation and software systems, as well as supporting Commissioning, Qualification, and Validation (CQV) activities for packaging, ASRS, and AGV systems. Collaboration with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams is essential for maintaining GxP compliance. The role also involves ensuring commissioning and qualification activities align with project requirements, milestones, and schedule commitments, applying engineering principles across automation, controls, robotics, and integrated systems, and demonstrating a strong understanding of OT/IT convergence, industrial networks, and system integration. Support and review of machine controls design, including PLCs and HMI/SCADA platforms, as well as site computer systems validation (CSV) activities and data integrity requirements, are also key responsibilities. The engineer will work closely with ASRS and AGV vendors/consultants, ensuring contracts, technical specifications, and deliverables meet requirements, and collaborate with users, peers, and management for standardization and alignment. The role requires the ability to lead cross-functional initiatives, encourage critical, creative problem-solving, and effectively lead and influence teams to achieve technical outcomes and strong collaboration.

Requirements

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

Nice To Haves

Willing to travel to manufacturing/customer sites when required.

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.