Sr. Engineer II, Drug Product Automation

Role: Senior Automation Engineer leading the development, governance, and lifecycle management of automation and control systems supporting Drug Product manufacturing processes such as Filling, Packaging, and Visual Inspection. Responsibilities include establishing automation standards, designing scalable digital architectures, overseeing system integration, supporting capital projects, and ensuring compliance with GMP, validation, and cybersecurity requirements. The role involves technical leadership across system design, startup, qualification, troubleshooting, and regulatory audits, with a focus on Rockwell/Siemens PLCs, SCADA platforms (e.g., Wonderware), and data architecture aligned with ISA-88 and ISA-95 principles. Collaborates extensively with Manufacturing, MS&T, Quality, IT, and external vendors, providing mentorship and driving continuous improvement initiatives, including leveraging AI for automation workflows. Qualifications: Bachelor’s in Electrical, Mechanical, Computer Science, or Automation Engineering; at least 6 years’ experience in controls engineering, preferably within biopharma or biotech manufacturing supporting Drug Product operations; deep expertise in automation hardware/software, GxP systems, and lifecycle management; strong knowledge of validation, change control, and cybersecurity. Preferred skills include experience with PackML, serialization, machine vision, robotics, automation programming languages, and regulatory inspections. The position is onsite with potential off-hours support, requiring cross-functional leadership, technical expertise, and industry-standard controls knowledge to optimize manufacturing automation infrastructure.