Automation Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and assist with facility automation and control systems to guarantee safe, compliant, and dependable operations in line with cGMP, data integrity, and regulatory standards.

• Deliver hands-on automation assistance for manufacturing and pilot plant activities, encompassing real-time troubleshooting, system monitoring, and performance enhancement.

• Lead and assist capital projects that involve the design, implementation, startup, commissioning, qualification, and lifecycle management of new automation systems and equipment upgrades.

• Set up, 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 resolve issues and enact sustainable automation enhancements.

• Support computerized system lifecycle activities by 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).

• Conduct automation system administration tasks, including user access management, backups, patch management, system monitoring, asset lifecycle management, and implementation of data integrity controls.

• Engage in investigations, deviations, Quality Notifications (QNs), and Corrective and Preventive Actions (CAPAs), ensuring prompt resolution of automation-related quality issues.

• Produce clear and precise technical documentation in compliance with cGMP standards and internal procedures.

• Propel continuous improvement initiatives aimed at automation reliability, system performance, modernization, and operational efficiency.

• Provide technical guidance and mentorship to junior engineers, technicians, and cross-functional team members as required.

⛳️ Requirements

• A minimum of 2 years of practical experience in automation, process controls, or industrial control systems within a GMP-regulated manufacturing setting.

• Strong background with automation platforms such as PLC systems (e.g., Allen-Bradley, Siemens), Distributed Control Systems (DCS), with a preference for DeltaV experience, SCADA platforms, and batch control systems in accordance with ISA-88 and ISA-95 standards.

• In-depth knowledge of control logic, instrumentation, industrial networks, and automation system architecture.

• Experience in supporting computerized systems throughout the system development lifecycle (SDLC) and computer system validation (CSV) processes.

• Familiarity with change management, validation documentation, and regulatory compliance requirements within a GMP environment.

• Strong troubleshooting, analytical, and problem-solving abilities.

• Excellent verbal and written communication skills with the capacity to work efficiently both independently and in cross-functional teams.

• Willingness to support off-hours, rotating on-call responsibilities, and urgent manufacturing assistance as needed.

• Proven commitment to safety, quality, and operational excellence.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development