Manufacturing OT Support Engineer (Senior)
hace 4 días
East Windsor
Manufacturing OT Support Engineer (Senior) \n End Client: ANI Pharmaceuticals \n Job Title: Manufacturing OT Support Engineer \n Locations: East Windsor, NJ / Verona, WI / Baudette, MN \n Work Model: Onsite \n Contract Type: Contract \n Rate: Market Rate – Senior-Level Resource Required \n Experience: 10+ Years \n Travel: Up to 100% \n Work Authorization: US Work Authorization Required; OPT, CPT, and H-1B Transfer candidates are not eligible \n Position Overview \n 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. \n 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. \n 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. \n Key Responsibilities \n\n • Provide L2/L3 technical support for manufacturing OT environments, including MES, SCADA, HMI, Historian, and other shop-floor applications.\n, • Troubleshoot and resolve issues involving PLC connectivity, OPC/OPC-UA, MQTT, Modbus, and other industrial communication protocols.\n, • Diagnose manufacturing system connectivity, application, network, and integration issues affecting production operations.\n, • Provide onsite support for production incidents, equipment connectivity issues, system failures, downtime events, and recovery activities.\n, • Monitor OT systems and perform routine system health checks, performance monitoring, preventive maintenance, and operational assessments.\n, • Investigate recurring issues and perform root-cause analysis to identify permanent corrective actions.\n, • Support approved configuration changes, application updates, patches, system maintenance, and controlled deployments.\n, • Work closely with plant operations, manufacturing engineering, automation, IT infrastructure, cybersecurity, quality, and validation teams.\n, • Coordinate with OEMs, system integrators, software vendors, and other third parties for troubleshooting and resolution of complex technical issues.\n, • Support integration and connectivity between manufacturing applications, equipment, PLCs, databases, and enterprise systems.\n, • Utilize SQL Server to troubleshoot, validate, and investigate manufacturing application and data-related issues.\n, • Maintain accurate incident records, troubleshooting documentation, system documentation, and operational procedures.\n, • Follow established change control, incident management, problem management, and escalation procedures.\n, • Support GMP/GxP compliance, audit readiness, electronic records requirements, and documentation practices applicable to pharmaceutical manufacturing.\n, • Participate in system recovery, disaster recovery, and business continuity activities for critical manufacturing OT systems.\n, • Identify opportunities to improve OT system reliability, availability, maintainability, and operational performance.\n, • Travel to and support different manufacturing facilities as required by the business.\n, • Remain flexible regarding long-term onsite assignments and relocation between East Windsor, NJ; Verona, WI; and Baudette, MN.\n\n Required Qualifications \n\n • 10+ years of professional experience in Manufacturing OT, Industrial Automation, Controls, Manufacturing Systems, or a closely related field.\n, • Strong hands-on experience supporting manufacturing OT environments in production facilities.\n, • Proven experience with MES, SCADA, HMI, and Historian systems.\n, • Strong understanding of PLC systems and PLC-to-application connectivity.\n, • Hands-on knowledge of industrial communication and integration technologies, including:\n, • OPC / OPC-UA\n, • MQTT\n, • Modbus\n, • Industrial networking and connectivity concepts\n, • Strong experience troubleshooting shop-floor systems and manufacturing application connectivity.\n, • Experience working with Microsoft SQL Server and SQL-based troubleshooting.\n, • Experience supporting production-critical systems and resolving high-priority incidents in an operational environment.\n, • Strong understanding of system monitoring, troubleshooting, incident resolution, root-cause analysis, and preventive maintenance.\n, • Strong communication skills with the ability to work effectively with plant personnel, technical teams, vendors, and business stakeholders.\n, • Ability to work independently in a fast-paced manufacturing environment and manage multiple technical priorities.\n\n Preferred Qualifications \n\n • Experience supporting pharmaceutical, biotechnology, life sciences, or other GMP-regulated manufacturing environments.\n, • Knowledge of GMP/GxP, FDA-regulated environments, and computerized system compliance.\n, • Experience with manufacturing validation, change control, deviation management, and audit readiness.\n, • Familiarity with 21 CFR Part 11 and data integrity principles.\n, • Experience with OT cybersecurity concepts and secure industrial environments.\n, • Experience working with system integrators, OEMs, and manufacturing technology vendors.\n, • Experience supporting multi-site manufacturing environments.\n, • Exposure to MES/SCADA platforms, industrial historians, PLC platforms, and manufacturing data systems.\n\n Core Technical Skills \n (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) \n Work Location & Mobility Requirements \n This position requires a high level of geographic flexibility. The candidate must be willing to: \n\n • Work onsite at manufacturing facilities.\n, • Travel up to 100% based on project and business requirements.\n, • Accept long-term onsite assignments.\n, • Relocate between manufacturing locations when required.\n, • Support any of the following locations based on business needs:\n, • East Windsor, NJ\n, • Verona, WI\n, • Baudette, MN\n\n Candidates who require a fixed remote or hybrid arrangement are not suitable for this position. \n Work Authorization \n Candidates must be legally authorized to work in the United States. \n Not eligible: OPT, CPT, and H-1B Transfer candidates. \n Ideal Candidate Profile \n 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. \n Strong preference for candidates with pharmaceutical manufacturing and GMP/GxP experience, combined with extensive MES/SCADA/PLC/OPC troubleshooting expertise. \n