Specialist, Automation Engineer (Onsite)

Job description

Job Description The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides both technical and project management responsibility. The Specialist – Automation Engineer position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team in the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and the automation system assets spanning Pilot plant production, utility systems and associated IT-OT infrastructure.  Responsibilities of the Specialist – Automation Engineer include the following: The automation engineer role at the Specialist level will serve as technical resource to support new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network. Primarily, will support the Protein Engineering Microbial Infrastructure (PEMI) Project. This is a new non-GMP lab area and Plot Plant currently under construction in Rahway, New Jersey. The automation engineering role at the Specialist level will serve as a team member of the PEMI design, startup, and commissioning, supporting the integration of the PEMI SCADA system (an Ignition-based platform) that will perform data acquisition and orchestrate flexible batches / experiments on the following OEM equipment; Sartorius AMBR250 system, Getinge Fermenters/Bioreactors, Tangential Flow Filtration (TFF), two Lyophilizers & Containment Isolators, Homogenizers, Mixing tanks and Raman PAT integrations. As the facility is currently under construction, the selected candidate will contribute to automation scope and Ignition software design, system commissioning, as well as other critical activities to enable facility startup and operational readiness. The selected candidate is expected to be a key part of the EF Automation Team and foster a culture of collaboration, learning and innovation. This position will also require close collaboration with the development engineers & chemists, compliance representatives, and other team members. This role will be part of the broader Enabling Facilities team supporting facility operations, process development activities, compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities. Key Responsibilities: Troubleshoot automation and instrumentation issues, perform root cause analyses, and implement corrective and preventive actions to improve reliability, safety, and operational effectiveness. Manage system patches, firmware upgrades, backup and restore strategies, and cybersecurity hardening activities aligned with corporate IT policies. Ensure robust data integrity and audit trails that support operational requirements. Support capital projects involving the design, installation, and commissioning of new equipment, including the preparation, review, and execution of test documentation. Provide on-call support as part of the facility operations rotation. Collaborate closely with Operations, Maintenance, and IT teams to align automation solutions with uptime, safety, sustainability, and efficiency objectives. Support continuous improvement initiatives, including standardization, modular code libraries, alarm rationalization, and enhanced diagnostics and monitoring for utility equipment. Additional Supported Areas As required and in addition to support of current capital projects, the Specialist may provide direct support to other areas such as: GMP-capable Process Chemistry / Prep Lab facility that supports development and preparation of clinical and research materials, including ADC-related batches and process chemistry operations. Automation support may be required for Siemens PLC controlled Lyophilizer, Isolator HMIs, and SCADA interfaces. Small Scale Organics Pilot Plant (SSO): The SSO uses an Emerson DeltaV Distributed Control System.  The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization.  The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites. Hazardous Reactions Lab (HRL): The Hazardous Reactions Lab (HRL), uses GE PLC 90-30 processors and Genius I/O blocks. The Graphical interface is an Intellution iFix platform run on redundant SCADAS and seven workstations, with historical data collected on a local historian as well as OSI PI.  The B801 High Pressure Lab and Low-Pressure Lab Automation Systems support Hydrogenation Hazardous reactions using a wide variety of vessels and equipment.  The High-Pressure Barricades Cells are divided up into ten cells where each cell is electrically classified as Class 1 Division 2 Hazardous Area, Group B. Education Minimum Requirement: Bachelor’s degree in Automation, Engineering, Science, or Computer-Science or related technical discipline with minimum of 3 years of progressive automation or process control experience in a regulated GxP environment (biopharmaceuticals, pharmaceuticals or medical devices) Required Experience and Skills: Core Systems: Proven technical proficiency with industrial PLC, HMI, and SCADA platforms (e.g., Rockwell and/or Siemens). Experience with SCADA systems. Experience with AVEVA PI System or comparable historian platforms. Strong problem-solving and troubleshooting skills, including experience with root cause analysis. Ability to prepare and review Standard Operating Procedures (SOPs) and cGMP documentation. Experience working with Quality Systems. Effective verbal and written communication skills. Strong organizational skills with the ability to manage multiple priorities simultaneously. Demonstrated willingness to learn, grow, and contribute to team objectives. Knowledge of automation-related components, including wiring diagrams, electrical schematics, and system integration. Ability to work independently and collaboratively within cross-functional teams. Strong analytical thinking and technical writing skills. Proficiency with the Microsoft Office suite and document management systems. Ability to foster innovation, creativity, and initiative while effectively planning and organizing activities. Desired Experience and Skills: Experience with shop-floor digital integrations, including Ignition, ERP interfaces, and IoT smart sensor technologies. Experience with Ignition and Intellution iFIX Validation & Standards: Demonstrated experience delivering automation projects in alignment with SDLC and GAMP 5 methodologies, along with a solid working knowledge of ISA-88 and ISA-95 principles. Familiarity with distributed control systems (DCS), including Emerson DeltaV. Familiarity with industrial network architecture, server virtualization, and cybersecurity fundamentals. Experience with data analytics and self-service business intelligence (BI) platforms. Prior experience supporting regulatory agency audits or health authority inspections (e.g., HPRA, FDA). Experience implementing business value initiatives or continuous improvement methodologies, including Agile and JIRA-based workflows. Working knowledge of OPC and Modbus communication interfaces. Experience with automation system design, startup, commissioning, and/or qualification activities. Understanding of object-oriented programming languages. Strong background in IT systems, particularly the integration of automation systems with enterprise IT environments. Networking experience, including working knowledge o