What are the responsibilities and job description for the Automation Engineer position at Orise?
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.
- 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.