Senior Automation Engineer, Drug Product–Aseptic Filling

Role: Automation Engineer, Drug Product – Aseptic Filling, focusing on automation and controls for sterile manufacturing operations. Responsibilities: design, implement, qualify, troubleshoot, and support automation systems for aseptic filling; collaborate with Manufacturing, Process Engineering, Quality, and OEM vendors; oversee automation lifecycle, perform validations, and ensure system compliance with cGMP, GAMP 5, and cybersecurity standards; support automation interfaces with MES, historian, and data platforms; lead FAT/SAT, start-up, and troubleshooting activities; and manage automation documentation and regulatory inspections. Requirements: Bachelor's in Engineering, Computer Science, or related field; minimum 6 years in pharmaceutical/biopharma automation, with extensive hands-on experience in ISA-95 Level 1 & 2 systems, PLC/DCS control, SCADA/HMI, and automation software development supporting aseptic or sterile manufacturing. Preferred: experience with aseptic filling equipment, isolator or barrier tech, batch control, robotics, and platforms like Rockwell, Siemens, or Emerson DeltaV. High-value: focus on aseptic filling, highly automated systems, Level 1 & 2 automation, validation, cGMP compliance, and working with OEMs/vendors. Location: Wilson, NC, onsite; travel >25% domestically and internationally for project activities.