Job Description:
One of our large clients is seeking a highly qualified Senior Control Systems Engineer to support the development, deployment, and sustainment of automated manufacturing systems used in the production of medical device products. This engineer will lead automation initiatives, ensure system reliability and regulatory compliance, and provide technical leadership across multiple engineering disciplines. The role is primarily focused on new equipment introduction, automation system development, and technical documentation in support of validation and qualification activities.
The engineer will be responsible for leading automation and control system efforts across the full project lifecycle, including design, programming, system integration, and validation. All work will be performed within a medical device regulated environment and must align with internal procedures, GAMP 5, and applicable GxP standards.
Responsibilities will include:
• Design, develop, and implement automation and control systems for manufacturing equipment, including PLCs, HMIs, SCADA, motion systems, and custom software applications
• Author and maintain automation system documentation, including User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and Software Design Specifications (SDS)
• Lead development of test plans, test protocols, and summary reports to support IQ/OQ/PQ validation activities in coordination with internal teams and external vendors
• Develop and modify PLC logic, HMI interfaces, robot programs, and supporting software tools
• Perform simulation, bench testing, and on-equipment commissioning activities
Required Skills & Experience: