Advanced Process Engineer

Abbott Laboratories; Alameda (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott in Alameda, CA is seeking an Advanced Process Engineer to lead manufacturing automation initiatives within TPM operations, translating R&D concepts into scalable production. You will design, validate, and sustain automated equipment and processes, partnering with Engineering, Quality, Supply Chain, and external manufacturers to deliver compliant, efficient solutions.

The role emphasizes process development, validation (IQ/OQ/PQ), data-driven improvements, and leadership of

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 10+ years in process or manufacturing automation in regulated industry.
• Hands-on automation design, integration, commissioning and validation.
• Experience with IQ/OQ/PQ and data-driven problem solving.

Responsibilities

• Lead design, development, and implementation of automated manufacturing systems.
• Develop URS, equipment specs, and acceptance criteria.
• Manage vendor selection, FAT, SAT, installation, and commissioning activities.
• Drive improvements in equipment performance, reliability, uptime, and throughput using data.
• Lead process development from R&D through commercial production.
• Create robust, repeatable manufacturing processes focused on automation and scalability.
• Develop and maintain manufacturing documentation, including SOPs, 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, process capability, and cost reduction.
• Lead IQ/OQ/PQ and TMV validation activities and ensure regulatory compliance.

Skills

Automation systems

Process validation IQ/OQ/PQ

Statistical analysis

Python/SQL

Education

Bachelor's degree in Engineering

Tools

Python

SQL

Job description

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.

Advanced Process Engineer – Automation & Manufacturing Systems

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.

Key Responsibilities

• 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.

Qualifications

• 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 IQ/OQ/PQ.
• 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.

Preferred Experience

• Experience supporting medical device manufacturing environments.
• Knowledge of Lean Manufacturing and Six Sigma methodologies.
• Experience working with third‑party manufacturing partners and technology transfers.
• Experience integrating manufacturing systems and workflows, including MES, QMS, ERP platforms, APIs, and database connectivity.

Core Competencies

• Automation Expertise: Strong knowledge of automation systems, robotics, vision systems, and manufacturing equipment integration.
• Technical Leadership: Ability to lead complex engineering initiatives and drive successful execution.
• Quality & Compliance: Understanding of regulatory requirements, validation, and risk management principles.
• Data-Driven Problem Solving: Ability to leverage analytics and statistical methods to optimize manufacturing performance.
• Cross-Functional Collaboration: Effective communicator and partner across technical and operational teams.
• Continuous Improvement Mindset: Focused on operational excellence, scalability, and sustainable process improvement.

Job Details

• Base pay: $114,000.00 – $228,000.00
• Job Family: Engineering
• Division: ADC Diabetes Care
• Location: United States – Alameda: 2801 Harbor Bay Parkway
• Additional Locations: none specified
• Work Shift: Standard
• Travel: Yes, 10 % of the Time
• Medical Surveillance: No
• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Español: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more.

With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life.

Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people.

They push the boundaries to help manage and treat some of life’s greatest health challenges.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.