This is a remote position. Position Summary The Automation Engineer is responsible for supporting, maintaining, and improving facility automation and process control systems to ensure safe, reliable, and compliant manufacturing operations. This role provides technical leadership for automation systems throughout their lifecycle, including design, implementation, troubleshooting, qualification, maintenance, and continuous improvement activities within a cGMP-regulated environment. The successful candidate will collaborate closely with Manufacturing, Process Engineering, Facilities, Quality Assurance, Information Technology, and external vendors to deliver robust automation solutions that support operational excellence and regulatory compliance. Primary Responsibilities 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. Education Requirements Bachelor’s degree in Electrical Engineering, Computer Engineering, Computer Science, Chemical Engineering, or a related technical discipline. Equivalent combination of relevant education and technical experience may be considered. Required Qualifications & Experience 2+ years of hands-on experience in automation, process controls, or industrial control systems within a GMP-regulated manufacturing environment. Strong experience with automation platforms such as: PLC systems (e.g., Allen-Bradley, Siemens) Distributed Control Systems (DCS), with DeltaV experience preferred SCADA platforms and batch control systems aligned with ISA-88 and ISA-95 standards Strong knowledge of control logic, instrumentation, industrial networks, and automation system architecture. Experience supporting computerized systems throughout the system development lifecycle (SDLC) and computer system validation (CSV) processes. Working knowledge of change management, validation documentation, and regulatory compliance requirements within a GMP environment. Strong troubleshooting, analytical, and problem-solving skills. Excellent verbal and written communication skills with the ability to work effectively both independently and within cross-functional teams. Ability to support off-hours, rotating on-call responsibilities, and urgent manufacturing support when required. Demonstrated commitment to safety, quality, and operational excellence.

Preferred Qualifications

Experience supporting biopharmaceutical manufacturing operations, including bulk drug substance, vaccine, or single-use manufacturing systems. Knowledge of Manufacturing Execution Systems (MES), process historians (e.g., PI), virtualization technologies, OT/IT networking, and industrial cybersecurity concepts. Experience managing small to medium automation projects, including project scope development, scheduling, vendor coordination, and execution. Experience supporting regulatory inspections and responding to audit observations. Familiarity with emerging automation technologies, digital transformation initiatives, and manufacturing data analytics. Key Competencies Technical leadership Automation troubleshooting and problem solving Project execution and organization Cross-functional collaboration Regulatory compliance mindset Continuous improvement and innovation Effective communication and documentation