Senior Automation Engineer – Aseptic Filling

About the role

The Automation Engineer for Drug Product – Aseptic Filling will own the technical automation and controls engineering for the aseptic filling area at Johnson & Johnson's Wilson site. Reporting to the Drug Product Manufacturing Lead, you will design, qualify, and support automation solutions that meet cGMP, data‑integrity, and cybersecurity standards.

Key responsibilities

• Lead end‑to‑end automation delivery from concept through design, FAT/SAT, commissioning, qualification, start‑up, and steady‑state support.
• Review and challenge OEM and system‑integrator designs, specifications, control narratives, and test documentation to ensure compliance with site and global standards.
• Develop, implement, and troubleshoot PLC/DCS/HMI/batch and machine‑control changes, maintaining standardized and documented configurations.
• Support automation interfaces to MES, historian, recipe/data platforms, ensuring reliable data flow and traceability.
• Author and execute validation and qualification documentation, and support risk assessments, investigations, CAPA, and regulatory inspections.

Required profile

• Minimum Bachelor’s degree in Engineering, Computer Science, Science or related field.
• At least 6 years of progressive automation and controls engineering experience in pharmaceutical or biopharmaceutical manufacturing.
• Hands‑on experience with ISA‑95 Level 1/2 systems, PLC/DCS, SCADA/HMI, batch control, industrial networks, and automation of aseptic filling operations.
• Proven track record of managing automation projects, including OEM coordination, FAT/SAT, commissioning, qualification, and start‑up.

Required skills

• PLC/DCS programming and configuration
• SCADA/HMI development
• ISA‑88 and ISA‑95 standards
• GAMP 5, cGMP, 21 CFR Part 11, EU GMP Annex 11 compliance
• Industrial networking and communication protocols
• Robotics and automated equipment integration