Manufacturing OT Support Engineer (Senior)
hace 3 días
East Windsor
Manufacturing OT Support Engineer (Senior) End Client: ANI Pharmaceuticals Job Title: Manufacturing OT Support Engineer Locations: East Windsor, NJ / Verona, WI / Baudette, MN Work Model: Onsite Contract Type: Contract Rate: Market Rate – Senior-Level Resource Required Experience: 10+ Years Travel: Up to 100% Work Authorization: US Work Authorization Required; OPT, CPT, and H-1B Transfer candidates are not eligible Position Overview ANI Pharmaceuticals is seeking a highly experienced Manufacturing OT Support Engineer to provide hands-on Operational Technology (OT) support across pharmaceutical manufacturing facilities. The ideal candidate will have strong experience supporting MES, SCADA, HMI, Historian, PLC connectivity, industrial communication protocols, and shop-floor manufacturing systems in a highly regulated production environment. This is a senior, hands-on onsite role requiring extensive travel and flexibility to work or relocate to different manufacturing facilities based on business requirements. The engineer will be responsible for maintaining system availability, troubleshooting production-impacting issues, supporting incident recovery, and ensuring OT systems operate reliably within a GMP/GxP-regulated pharmaceutical environment. The successful candidate must be comfortable working directly with plant operations, automation teams, IT, engineering, OEMs, and third-party vendors to resolve complex OT and manufacturing technology issues. Key Responsibilities • Provide L2/L3 technical support for manufacturing OT environments, including MES, SCADA, HMI, Historian, and other shop-floor applications., • Troubleshoot and resolve issues involving PLC connectivity, OPC/OPC-UA, MQTT, Modbus, and other industrial communication protocols., • Diagnose manufacturing system connectivity, application, network, and integration issues affecting production operations., • Provide onsite support for production incidents, equipment connectivity issues, system failures, downtime events, and recovery activities., • Monitor OT systems and perform routine system health checks, performance monitoring, preventive maintenance, and operational assessments., • Investigate recurring issues and perform root-cause analysis to identify permanent corrective actions., • Support approved configuration changes, application updates, patches, system maintenance, and controlled deployments., • Work closely with plant operations, manufacturing engineering, automation, IT infrastructure, cybersecurity, quality, and validation teams., • Coordinate with OEMs, system integrators, software vendors, and other third parties for troubleshooting and resolution of complex technical issues., • Support integration and connectivity between manufacturing applications, equipment, PLCs, databases, and enterprise systems., • Utilize SQL Server to troubleshoot, validate, and investigate manufacturing application and data-related issues., • Maintain accurate incident records, troubleshooting documentation, system documentation, and operational procedures., • Follow established change control, incident management, problem management, and escalation procedures., • Support GMP/GxP compliance, audit readiness, electronic records requirements, and documentation practices applicable to pharmaceutical manufacturing., • Participate in system recovery, disaster recovery, and business continuity activities for critical manufacturing OT systems., • Identify opportunities to improve OT system reliability, availability, maintainability, and operational performance., • Travel to and support different manufacturing facilities as required by the business., • Remain flexible regarding long-term onsite assignments and relocation between East Windsor, NJ; Verona, WI; and Baudette, MN. Required Qualifications • 10+ years of professional experience in Manufacturing OT, Industrial Automation, Controls, Manufacturing Systems, or a closely related field., • Strong hands-on experience supporting manufacturing OT environments in production facilities., • Proven experience with MES, SCADA, HMI, and Historian systems., • Strong understanding of PLC systems and PLC-to-application connectivity., • Hands-on knowledge of industrial communication and integration technologies, including:, • OPC / OPC-UA, • MQTT, • Modbus, • Industrial networking and connectivity concepts, • Strong experience troubleshooting shop-floor systems and manufacturing application connectivity., • Experience working with Microsoft SQL Server and SQL-based troubleshooting., • Experience supporting production-critical systems and resolving high-priority incidents in an operational environment., • Strong understanding of system monitoring, troubleshooting, incident resolution, root-cause analysis, and preventive maintenance., • Strong communication skills with the ability to work effectively with plant personnel, technical teams, vendors, and business stakeholders., • Ability to work independently in a fast-paced manufacturing environment and manage multiple technical priorities. Preferred Qualifications • Experience supporting pharmaceutical, biotechnology, life sciences, or other GMP-regulated manufacturing environments., • Knowledge of GMP/GxP, FDA-regulated environments, and computerized system compliance., • Experience with manufacturing validation, change control, deviation management, and audit readiness., • Familiarity with 21 CFR Part 11 and data integrity principles., • Experience with OT cybersecurity concepts and secure industrial environments., • Experience working with system integrators, OEMs, and manufacturing technology vendors., • Experience supporting multi-site manufacturing environments., • Exposure to MES/SCADA platforms, industrial historians, PLC platforms, and manufacturing data systems. Core Technical Skills (MES, SCADA, HMI, Historian, PLC, OPC, OPC-UA, MQTT, Modbus, SQL Server, Manufacturing OT, Industrial Automation, Shop-Floor Systems, Production Support, L2/L3 Support, Incident Management, Root Cause Analysis, System Monitoring, Preventive Maintenance, GMP, GxP, 21 CFR Part 11, Change Control, Pharmaceutical Manufacturing, OT Connectivity) Work Location & Mobility Requirements This position requires a high level of geographic flexibility. The candidate must be willing to: • Work onsite at manufacturing facilities., • Travel up to 100% based on project and business requirements., • Accept long-term onsite assignments., • Relocate between manufacturing locations when required., • Support any of the following locations based on business needs:, • East Windsor, NJ, • Verona, WI, • Baudette, MN Candidates who require a fixed remote or hybrid arrangement are not suitable for this position. Work Authorization Candidates must be legally authorized to work in the United States. Not eligible: OPT, CPT, and H-1B Transfer candidates. Ideal Candidate Profile The ideal candidate is a senior hands-on OT/Manufacturing Support Engineer with 10+ years of experience who can independently troubleshoot production-critical manufacturing systems. The candidate should be comfortable working directly on the plant floor, diagnosing MES/SCADA/PLC connectivity problems, coordinating with multiple technical teams, and operating within the documentation and compliance requirements of a pharmaceutical manufacturing environment. Strong preference for candidates with pharmaceutical manufacturing and GMP/GxP experience, combined with extensive MES/SCADA/PLC/OPC troubleshooting expertise.