Miratech Corporation

Role Description As a Qualification Engineer, you will perform Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical manufacturing equipment, facilities, and utilities. You will develop and execute commissioning and validation protocols while ensuring equipment and manufacturing systems comply with FDA regulations and Good Manufacturing Practices (GMP). This role is ideal for candidates with pharmaceutical validation, commissioning, quality engineering, manufacturing, automation, or military technical experience. - Develop and execute commissioning protocols. - Perform Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). - Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). - Perform process, cleaning, and computer systems validation. - Prepare validation plans, protocols, reports, and traceability documentation. - Ensure compliance with FDA, GMP, and regulatory requirements. - Participate in risk assessments and mitigation planning. - Collaborate with Quality, Manufacturing, Engineering, and Regulatory teams. - Support startup, equipment walkdowns, and troubleshooting. - Identify and implement continuous improvement opportunities. Qualifications - Bachelor's degree in engineering, Life Sciences, or related field. - 3-5 years of CQV experience in an FDA-regulated manufacturing environment. - Experience with FAT, SAT, IQ, OQ, PQ, URS, P&IDs, equipment startup, and validation. - Strong understanding of GMP and FDA regulations. - Excellent technical writing and documentation skills. - Ability to travel 50-70%. Requirements - Biotech manufacturing. - Aseptic processing. - Fill/Finish. - Gene Therapy. - GMP. - FDA compliance. - CQV. - Validation software. - ASQ Certified Quality Engineer. - Pharmaceutical manufacturing.

Role Description As a Process Engineer, you will support the design, startup, optimization, and continuous improvement of pharmaceutical manufacturing and packaging systems. You will work closely with customers, engineering teams, and commissioning personnel to improve manufacturing processes, optimize equipment performance, and ensure regulatory compliance throughout the project lifecycle. Responsibilities - Support process development and equipment optimization. - Assist with equipment startup and commissioning. - Evaluate manufacturing processes and recommend improvements. - Troubleshoot production and equipment issues. - Collaborate with engineering, validation, and quality teams. - Develop process documentation and technical reports. - Support FAT, SAT, and production startup activities. - Ensure compliance with GMP and FDA requirements. - Assist with customer training and technical support. - Support continuous improvement initiatives. Qualifications - Bachelor's degree in Engineering or related technical field. - Experience in pharmaceutical or regulated manufacturing. - Strong understanding of manufacturing processes. - Excellent troubleshooting and analytical skills. - Ability to travel 50-70%. - Strong communication and customer interaction skills. Requirements - Pharmaceutical packaging. - GMP. - FDA regulations. - Process optimization. - Automation systems. - PLC familiarity. - FAT/SAT. - Validation. - Lean Manufacturing. - Continuous Improvement.

Role Description As an Automation Controls Engineer, you will lead the programming, commissioning, startup, troubleshooting, and optimization of advanced automated packaging equipment at customer manufacturing facilities across North America. This highly technical role focuses on PLC programming, machine software modifications, controls integration, electrical troubleshooting, and automation system performance. You will work directly with customers, engineering teams, and international colleagues to support new equipment installations, upgrades, rebuilds, and continuous improvement initiatives while serving as the technical expert during machine startup and commissioning. This role is ideal for experienced Controls Engineers, Automation Engineers, PLC Programmers, Commissioning Engineers, or military technical professionals with advanced industrial controls and automation experience. Responsibilities - Program, modify, and troubleshoot Rockwell ControlLogix and Siemens PLC software. - Commission and start up new automated packaging equipment. - Adjust and optimize machine software parameters for maximum performance. - Troubleshoot complex electrical, controls, and automation issues. - Download, configure, and update PLC, HMI, and drive programs. - Develop test protocols, validation documentation, and automation change controls. - Perform root cause analysis and implement continuous improvement initiatives. - Document software revisions and maintain updated machine programs. - Interface directly with customers, subcontractors, and engineering teams to resolve technical issues. - Support machine upgrades, rebuilds, and automation improvements. Qualifications - Bachelor's degree in electrical engineering, Computer Engineering, Automation, or related field preferred (or equivalent experience). - Minimum 3-5 years of experience with industrial automation or high-speed automated equipment. - Expert knowledge of Allen-Bradley (ControlLogix) and Siemens PLC platforms. - Experience with PLC programming, commissioning, and startup of automated equipment. - Strong understanding of industrial electrical controls, HMIs, servo systems, and motion control. - Ability to read electrical schematics, control diagrams, and P&IDs. - Excellent customer communication and technical problem-solving skills. - Ability to travel 50-75%. Nice-to-Have Skills - Rockwell ControlLogix - Siemens PLC - RSLogix 5000 - FactoryTalk View SE - Wonderware - Ignition SCADA - Motion Control - Servo Drives - VMware - SAP - Validation documentation - Pharmaceutical packaging equipment - GMP / FDA regulated manufacturing - Lean Six Sigma / Root Cause Analysis - IEC electrical diagrams - Machine commissioning and startup

Role Description As an Automation & Controls Technician, you will support the installation, startup, commissioning, troubleshooting, and service of advanced automated packaging equipment at customer manufacturing facilities across North America. This hands-on position focuses on industrial automation, electrical controls, PLC systems, HMIs, drives, sensors, and machine commissioning. You'll work directly with customers while supporting machine upgrades, improving equipment performance, and assisting Controls Engineers with programming modifications. This role is ideal for candidates with industrial automation, controls, mechatronics, PLC, packaging equipment, or military electrical/electronic experience. Responsibilities - Install and commission automated packaging equipment. - Perform electrical wiring, field installations, and panel assembly. - Troubleshoot PLCs, HMIs, drives, and electrical controls. - Download PLC, HMI, and drive programs. - Perform machine upgrades and process improvements. - Tune PID loops and support commissioning activities. - Interface directly with customers and subcontractors. - Read and interpret IEC electrical diagrams. - Troubleshoot industrial sensors, servos, drives, and control devices. - Support Controls Engineers with programming improvements. Qualifications - Associate degree in Mechatronics, Electro-Mechanical Technology, or related field (or equivalent experience). - Minimum 2 years supporting industrial automation equipment. - Strong electrical troubleshooting skills. - Experience with PLCs, HMIs, industrial controls, and automation. - Ability to read electrical schematics. - Excellent customer communication skills. - Ability to travel 70-80%. Requirements - Rockwell ControlLogix. - CompactLogix. - Allen-Bradley. - Servo drives. - VFDS. - SAP. - GMP/GDP manufacturing. - Pharmaceutical packaging. - 21 CFR Part 11. - PID tuning. - Commissioning experience.