{"id":1639373,"url":"https://alion.io/job/enable-injections-staff-controls-engineer","title":"Staff Controls Engineer","company":{"id":2363129,"name":"Enable Injections","domain":"enableinjections.com","url":"https://alion.io/company/enableinjections","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"staff","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cincinnati, United 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Mechatronics, or related Engineering from an accredited university.\nA minimum of 10 years of controls and automation engineering experience supporting automated manufacturing equipment in a regulated industry (medical device, pharmaceutical, or similar); or a master’s degree plus 6 years of experience.\nProven hands-on experience designing, programming, and integrating highly automated assembly and test equipment, including PLC-based control systems, HMI/SCADA architectures, robotics, and motion control.\nDemonstrated experience collaborating with cross-functional project teams and automation suppliers.\nExperience supporting automated production equipment in a high-volume manufacturing environment (1M+ units annually, cycle time less than 10 seconds).\nAdvanced proficiency programming and architecting Allen-Bradley PLC platforms (e.g., CompactLogix, ControlLogix) in ladder logic and/or structured text, HMI development (e.g., Ignition), SCADA systems, and industrial data collection/database architectures (e.g., MS SQL).\nExperience with automated testing, vision inspection, and servo-driven motion platforms.\nDeep understanding of robotic systems (SCARA, Cartesian, and collaborative robots) and industrial networking protocols (EtherNet/IP, OPC-UA).\nDemonstrated ability to improve Overall Equipment Effectiveness (OEE) through controls and automation engineering, including PLC/HMI/SCADA-based downtime and fault data collection, alarm and diagnostic strategies, and cycle-time and motion optimization.\nPreferred:\nProficiency with SolidWorks, Minitab, and Microsoft Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook).\nKnowledge of Good Automated Manufacturing Practice (GAMP) 5, International Organization for Standardization (ISO) 13485, and Title 21 CFR Part 820 and Part 11 for equipment and software validation.\nExperience with cleanroom manufacturing (International Organization for Standardization (ISO) Class 8) and contamination control strategies.\nVendor automation or robot certifications, or hands-on programming experience specific to FANUC, ABB, or Epson controllers.\nExperience with capital automation equipment procurement and project management, including supplier evaluation and contract negotiation.\nSix or more years of experience participating in equipment, software, and computer system validation and qualification activities (IQ, OQ, PQ) in compliance with FDA 21 CFR Part 820 and Part 11.\nSkills & Competencies:\nProficient in controls system design and equipment lifecycle management.\nExperienced in software and equipment validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).\nAdvanced skills in automated equipment performance optimization, controls and production data analysis, and structured root-cause problem solving.\nEffective communicator with excellent technical writing and presentation skills.\nStrong skills in supplier management and technical coaching.\nWorking knowledge of Lean Six Sigma, process capability analysis (Cp, Cpk, Ppk), and Measurement System Analysis (MSA) as applied to automated assembly, test, and inspection equipment.\nExperience facilitating equipment-focused kaizen events, Design of Experiments (DOE) studies, and Statistical Process Control (SPC) monitoring using automated data collection from production equipment.\nDeep understanding of Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, SQL-based data collection databases, and automation data connectivity for traceability and performance tracking.\nAdaptability and resilience in dynamic, high-volume manufacturing environments.\nAdvanced troubleshooting and optimization of PLC, HMI, and SCADA-based control systems supporting automated production equipment.\nSkilled in robot programming, motion control tuning, and vision system calibration for automated assembly and inspection equipment.\nAbility to navigate ambiguity and influence technical decisions at the department and organizational level.\nFamiliarity with project management fundamentals and tools (e.g., Microsoft Project) to plan and execute capital equipment projects.\nPhysical Requirements:\nMust be able to remain in a stationary position for extended periods of time.\nAbility to constantly operate a computer and other office equipment, such as printer, telephone, etc.\nAbility to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time.\nMust be able to access and navigate all areas of the facility, including cleanrooms.\nPosition requires being physically present on the premises during regular company hours or as approved by management\nRESPONSIBILITIES:\nDesign, specify, and implement fully automated assembly and test equipment control systems, including PLC, HMI, SCADA, robotics, motion control, and vision inspection integration.\nSupport the development of electrical, controls, and software architecture for new automation equipment, from concept and prototyping through fabrication, programming, and final validation testing.\nProgram, configure, and troubleshoot PLCs (Allen-Bradley), HMIs (e.g., Ignition), SCADA systems, and robotic controllers supporting automated production lines.\nLead troubleshooting and continuous improvement efforts for automated equipment controls to enhance performance, quality, and reliability.\nSupport process, software, and computer system validation activities (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)) and documentation in compliance with Food and Drug Administration (FDA) 21 CFR Part 820 and Part 11, and International Organization for Standardization (ISO) standards.\nDevelop and implement Standard Operating Procedures, operator and technician training, and qualification documentation for automated equipment control systems, including software configuration management and change control.\nLead capital automation equipment procurement, including supplier evaluation, design reviews, and Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs).\nDrive improvements in Overall Equipment Effectiveness (OEE), yield, and throughput on automated production equipment through controls enhancements - PLC and HMI code optimization, motion tuning, fault diagnostics, and equipment data analysis - supported by Lean Six Sigma tools.\nProvide technical guidance and mentorship to engineers and technicians on controls and automation design practices.\nDevelop and maintain Quality System documentation related to automated manufacturing equipment, control systems, and automation software.\nCollaborate with cross-functional teams (product development, manufacturing, quality, and regulatory) to deliver automation and controls engineering project goals on time and within budget.\nSupport risk management through Failure Mode and Effects Analysis (FMEA) and other 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