An Automation Engineer develops and implements testing strategies and toolsets with the goal of increasing process automation. Establishes appropriate measures to validate and report on software quality. Designs and implements test automation to improve system reliability and stability. Designs and supports frameworks for test infrastructure. Provides automation expertise and mentoring.
Automation Engineer PA Solutions - 3.2 Lewis Center, OH Job Details 10 days ago Qualifications Material handling systems Data integrity assurance Electrical automation system implementation Bachelor's degree in mechanical engineering EPA Systems integration Software engineering Project engineering Packaging machines Requirements specification Requirements design Bachelor's degree in electrical engineering Field service Technical documentation Safety regulations Mechanical Engineering Software implementation Mechanical system commissioning projects Robotics engineering Production safety compliance IoT systems English
FDA 21 CFR
Part 11 GMP Mid-level Electrical engineering System design for system development Data integrity and documentation Vendor compliance management Bachelor's degree in engineering Full 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.
