Genovice

QA Automation Engineer

• Maintain and support facility automation and control systems to ensure safe, compliant, and reliable operations in accordance with cGMP, data integrity, and regulatory requirements.
• Provide hands-on automation support for manufacturing and pilot plant processes, including real-time troubleshooting, system monitoring, and performance optimization.
• Lead and support capital projects involving the design, implementation, startup, commissioning, qualification, and lifecycle management of new automation systems and equipment upgrades.
• Configure, troubleshoot, test, and maintain automation platforms including Distributed Control Systems (DCS), Programmable Logic Controllers (PLC), SCADA systems, and batch automation systems.
• Collaborate with Process Engineering, Manufacturing, Facilities, IT, Quality Assurance, and OEM vendors to investigate issues and implement sustainable automation improvements.
• Support computerized system lifecycle activities, including authoring, reviewing, and executing SDLC/CSV documentation such as User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), and Operational Qualification (OQ).
• Perform automation system administration activities including user access management, backups, patch management, system monitoring, asset lifecycle management, and implementation of data integrity controls.
• Participate in investigations, deviations, Quality Notifications (QNs), and Corrective and Preventive Actions (CAPAs), ensuring timely resolution of automation-related quality events.
• Prepare clear and accurate technical documentation in accordance with cGMP requirements and internal procedures.
• Drive continuous improvement initiatives focused on automation reliability, system performance, modernization, and operational efficiency.
• Provide technical leadership and mentorship to junior engineers, technicians, and cross-functional team members as needed.