Equipment and Automation Engineer II

Abbott Laboratories is seeking an Equipment and Automation Engineer II to support biotechnology and pharmaceutical manufacturing operations. In this role, you will design, implement, and optimize automated equipment and control systems to improve reliability, throughput, and product quality in a regulated GMP environment. You will lead equipment qualification, support validation, develop and maintain SOPs, and drive root cause investigations. Partnering with manufacturing, quality, and R&D, you will execute continuous improvement projects, ensure regulatory compliance, and contribute to safe, efficient, and innovative production systems.

Responsibilities

• Design, implement, and support automated equipment and control systems for biotech/pharma manufacturing.

• Lead and execute equipment qualification and support validation activities (IQ/OQ/PQ).

• Ensure equipment and automation systems comply with c

• GMP, FDA, and internal quality standards.

• Troubleshoot equipment and automation issues and drive root cause analysis and corrective actions.

• Develop and maintain technical documentation, including URS, SOPs, and validation protocols.

• Collaborate with manufacturing, quality, and R&D on process improvements and technology transfers.

• Identify and implement continuous improvement projects to enhance reliability, safety, and throughput.

• Support change control, risk assessments, and CAPA related to equipment and automation.

• Monitor equipment performance using data analysis and implement optimization strategies.

• Provide technical training and guidance to operations and maintenance teams.

Required Skills

• Equipment validation (IQ/OQ/PQ)

• Automation/controls engineering (PLC, SCADA, HMI)c

• GMP and FDA/ISO regulatory compliance

• Process development and optimization

• Technical troubleshooting and root cause analysis

• Change control and CAPA systems

• Data analysis and reporting

• Technical documentation (URS, SOPs, protocols)

• Cross-functional project coordination

• Risk assessment (FMEA or similar)