Senior Manufacturing Process Engineer - Process Improvement

Abbott (abbottcareers2 board); United States; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Education benefits (FreeU)

Diversity & recognition

Job summary

Abbott is a global healthcare leader dedicated to improving life through diagnostics, devices, nutrition, and medicines. The Senior Manufacturing Process Engineer role sits in the Infectious Disease Business Unit in Scarborough, Maine, focusing on leading equipment initiatives, quality improvements, and cost reductions across the operation.

You will drive process optimization, validate production changes, and collaborate with Quality, R&D, Supply Chain, and Regulatory to ensure compliance and

Qualifications

• Professional behavior with internal and external partners.
• Understand and maintain awareness of quality and compliance implications.
• Support department.

Responsibilities

• Own and maintain manufacturing processes, ensuring alignment with product specifications, process capabilities, and test method requirements.
• Lead process and equipment improvement initiatives to enhance quality, efficiency, throughput, and cost performance.
• Evaluate and implement manufacturing and design alternatives using Design for Manufacturability (DFM) principles.
• Solve complex technical challenges using structured problem-solving methodologies, statistical tools, and data-driven decision making.
• Design and execute engineering studies, including DOE methodologies, to support process optimization and validation activities.
• Lead equipment implementation, startup, qualification, and process validation activities, including IQ/OQ/PQ protocol development and execution.
• Ensure compliance with Design Controls, Process Validation requirements, FDA regulations, ISO standards, cGMP requirements, and internal Quality Management System (QMS) processes.
• Support Quality Incidents, CAPA investigations, root cause analysis, and implementation of corrective and preventive actions.

Job description

Abbott is a global healthcare leader dedicated to improving life through diagnostics, devices, nutrition, and medicines. The Senior Manufacturing Process Engineer role sits in the Infectious Disease Business Unit in Scarborough, Maine, focusing on leading equipment initiatives, quality improvements, and cost reductions across the operation.

You will drive process optimization, validate production changes, and collaborate with Quality, R&D, Supply Chain, and Regulatory to ensure compliance and