Advanced Process Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

The Advanced Process Engineer – Automation & Manufacturing Systems is the technical lead for manufacturing process development and automation within Third-Party Manufacturer (TPM) Operations. This role is responsible for developing, integrating, validating, and sustaining automated manufacturing equipment and processes as products transition from R&D into commercial production. The ideal candidate brings deep expertise in automation, manufacturing systems, process validation, and continuous improvement. This individual will partner across Engineering, Operations, Quality, Supply Chain, and external manufacturing partners to deliver scalable, compliant, and efficient manufacturing solutions.

Automation & Equipment Engineering Lead the design, development, and implementation of automated manufacturing systems, including robotics, machine vision, and integrated production equipment. Develop User Requirement Specifications (URS), equipment specifications, and acceptance criteria. Manage vendor selection, equipment development, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), installation, and commissioning activities. Drive improvements in equipment performance, reliability, uptime, and overall manufacturing efficiency using data-driven methodologies. Process Development & Manufacturing Transfer Lead process development and scale-up activities from R&D through commercial production. Design robust, repeatable manufacturing processes with a focus on automation and scalability. Develop and maintain manufacturing documentation, including SOPs, work instructions, PFMEAs, control plans, validation protocols, and DOE reports. Establish validated process parameters and operating ranges using statistical analysis. Evaluate manufacturing line layouts, capacity, and cycle times to optimize throughput and efficiency. Drive continuous improvement initiatives focused on yield enhancement, process capability, and cost reduction. Validation & Regulatory Compliance Lead IQ, OQ, PQ, and TMV activities for equipment and manufacturing processes. Ensure compliance with ISO 13485, 21 CFR Part 820, and other applicable regulatory standards. Conduct risk assessments using PFMEA and support ISO 14971 risk management activities. Manage change control activities for equipment, processes, and validated systems. Project Leadership Develop and execute project plans, timelines, and technical deliverables for automation and process engineering programs. Monitor project milestones, identify risks, and communicate progress to stakeholders. Collaborate with cross-functional teams and external manufacturing partners to achieve project objectives. Manufacturing Performance & Continuous Improvement Monitor key manufacturing metrics, including first-pass yield, cycle time, equipment uptime, and defect rates. Implement process monitoring and data collection strategies to support operational excellence. Troubleshoot process and equipment issues using structured problem-solving methodologies. Support ongoing manufacturing operations through process optimization and technical leadership.

Required Bachelor's degree in Engineering or a related technical discipline. 10+ years of experience in process engineering, manufacturing engineering, or automation within a regulated industry. Hands-on experience with automated equipment design, integration, commissioning, and validation. Demonstrated success implementing automation solutions that improve efficiency, throughput, and product quality. Strong experience with process validation methodologies, including