Senior Automation Engineer - Synerlution

Job Summary Objective

The Senior Automation Engineer plays a key role in the design, implementation, and lifecycle management of automated systems supporting pharmaceutical and medical device manufacturing. This position is responsible for leading automation projects that ensure reliable, compliant, and efficient production operations while maintaining adherence to FDA, cGMP, and GAMP 5 standards. Also, it will provide technical leadership, support validation efforts, drive continuous improvement initiatives, and collaborate across engineering, quality, and production teams to maintain and enhance control systems used in manufacturing, utilities, and laboratory environments.

Key Responsibilities

Lead the design, configuration, programming, and integration of automation and control systems, including PLCs, DCS, HMIs, and SCADA. Apply hands-on experience with automation platforms such as: PLC: Allen-Bradley (ControlLogix), Siemens, Schneider. HMI/SCADA: Wonderware, Ignition, FactoryTalk View, Aveva System Platform DCS: DeltaV, Honeywell, ABB. Develop automation architectures that ensure data integrity, system reliability, and compliance with 21 CFR Part 11. Leverage experience with data historians, batch control, and MES integration to optimize process performance. Collaborate with vendors and integrators on system design, FAT/SAT execution, and commissioning activities. Provide technical support and troubleshooting for process control systems, instrumentation, and network communication issues. Lead root cause investigations and implement corrective/preventive actions (CAPA) related to automation systems. Monitor system performance and drive continuous improvement initiatives to enhance reliability, efficiency, and compliance. Develop and maintain User Requirements Specifications (URS), Functional Design Specifications (FDS), and detailed design documentation. Support and lead Computer System Validation (CSV) activities, including development and execution of IQ/OQ/PQ protocols in alignment with GAMP 5. Ensure all system changes follow the site Change Control, Risk Assessment, and Deviation processes. Maintain complete and compliant documentation aligned with cGMP, FDA, and ISO quality requirements. Plan and execute automation projects from concept through startup, ensuring scope, schedule, and budget adherence. Coordinate with cross-functional teams, including Process Engineering, Quality, Validation, Maintenance, and IT. Mentor and guide junior automation engineers and technicians, fostering technical knowledge and adherence to best practices. Evaluate emerging technologies, propose modernization initiatives, and participate in digital transformation projects (MES, data historians, etc.).

Profile and Qualifications

Bachelor’s degree in Electrical Engineering, Control Systems, Computer Engineering, or related field. Minimum 7+ years of experience in automation and control systems within pharmaceutical, biotechnology, or medical devices manufacturing environments. Advanced proficiency in PLC/DCS programming, SCADA/HMI configuration, CSV, and software lifecycle processes. Strong knowledge of computer system lifecycle, change control, and FDA regulatory requirements. Hands-on experience with Rockwell Automation, Siemens, Wonderware, or similar platforms. Proficiency with databases (MS SQL), and networking infrastructure. Experience with data historian tools (OSI PI or equivalent). Ability to read and interpret electrical and mechanical drawings. Strong problem-solving, project management, and communication skills. Bilingual English/Spanish required.

Synerlution is committed to providing equal employment opportunities for all employees and applicants, regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, or veteran status. We feel that having a diverse staff increases our capacity to drive synergy through solutions for our clients. We are committed to fostering an inclusive environment in which all employees feel comfortable sharing their unique ideas and talents.