Summary: The Automation Engineer role is a contract position within a global pharmaceutical manufacturing organization, focusing on the development and implementation of automation processes for a new manufacturing facility in North Carolina. The position involves collaboration with system integrators and requires expertise in cGMP environments and FDA regulations. This is an opportunity to contribute to significant organizational growth and technological advancements in drug manufacturing.

Key Responsibilities:

• Work with a System Integrator to design and implement functional changes to support the installation of new equipment and development of new processes for a Tech Transfer
• Perform simulations of the DeltaV logic to ensure proper functionality
• Support and implement Automation-specific configuration of process formula parameters resulting from a technology transfer utilizing a custom FDB-specific product configuration system (CEBA)
• Review life cycle documentation
• Review and approve Kneat documents including: DeltaV software FATs, SATs, Automation Commissioning Test Protocols, software OQs, and Software Installation Verification protocols.

Key Skills:

• Experience in a cGMP pharmaceutical facility working with FDA regulations
• Knowledge with Drug Substance Manufacturing (DSM) and Upstream process equipment
• Working knowledge of Kneat or other electronic validation software
• Working knowledge of PLC based control systems such as Allen-Bradley and Siemens
• Excellent organizational, oral, and written communication skills and fluency in English

Salary (Rate): undetermined

City: undetermined

Country: United States

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other