Senior Automation Engineer

Role: Automation Engineer specializing in sterile pharmaceutical manufacturing, responsible for designing, qualifying, supporting, and maintaining automation and control systems to ensure compliant, reliable operations. Key responsibilities include developing automation solutions, programming PLCs, HMIs, SCADA, DCS, and BMS systems; supporting capital projects, technology transfers, commissioning, and lifecycle management; diagnosing and troubleshooting control and instrumentation issues; and ensuring compliance with cGMP, data integrity, and cybersecurity standards. The role involves collaboration with Manufacturing, Quality, Validation, IT/OT teams, vendors, and integrators, supporting validation activities, change management, and continuous improvement initiatives. Qualifications: Bachelor’s degree in Electronics, Mechatronics, Electrical, or Controls Engineering (Master’s preferred), with 5+ years’ experience in controls engineering within sterile GMP pharma, biotech, or life sciences manufacturing. Deep expertise in industrial automation platforms, control system design, troubleshooting, and validation principles; familiarity with GAMP, electronic records, risk assessments, and inspection readiness. Additional requirements include strong project management, vendor coordination, troubleshooting skills, and successful completion of OSHA-compliant respirator fit testing. High-value specifics: focus on sterile/aseptic manufacturing, process control system validation, GxP compliance, and lifecycle management of automation systems in a regulated biopharma setting.