Senior Automation & Process Engineer - Manufacturing

Abbott (abbottcareers2 board); United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Abbott in the United States is seeking an Advanced Process Engineer - Automation & Manufacturing Systems to lead automation within Third-Party Manufacturer (TPM) Operations, developing, validating, and sustaining automated equipment and processes as products move from R&D into commercial production.

The role partners with Engineering, Operations, Quality, Supply Chain, and external manufacturers to deliver scalable, compliant solutions, driving process development, validation, and continuous

Qualifications

• Bachelor's degree in Engineering (or 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 IQ/OQ/PQ validation methodologies.
• Proficiency in statistical analysis and process optimization techniques.
• Experience with programming or scripting tools such as Python, SQL, or similar technologies for process automation, data analysis, and reporting.

Responsibilities

• Lead the design, development, and implementation of automated manufacturing systems, including robotics, machine vision, and integrated production equipment.
• Develop URS, equipment specifications, and acceptance criteria.
• Manage vendor selection, equipment development, FAT, SAT, installation, and commissioning activities.
• Drive improvements in equipment performance, reliability, uptime, and overall manufacturing efficiency using data-driven methodologies.
• 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.
• 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.
• 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.
• 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.

Skills

Automation systems

Data analysis

Statistical methods

Programming / scripting

Education

Bachelor's degree in Engineering

Tools

Python

SQL

ERP systems

QMS

Job description

Abbott in the United States is seeking an Advanced Process Engineer - Automation & Manufacturing Systems to lead automation within Third-Party Manufacturer (TPM) Operations, developing, validating, and sustaining automated equipment and processes as products move from R&D into commercial production.

The role partners with Engineering, Operations, Quality, Supply Chain, and external manufacturers to deliver scalable, compliant solutions, driving process development, validation, and continuous