Validation Engineer

Position

• Senior Validation Engineer, Local Type
• ONSITE Location
• Lebanon, IN Visa
• GC Key Responsibilities Engineering & System Design Design and develop BMS and automation solutions for GMP/GxP-regulated pharmaceutical, biotech, and life sciences facilities.

Support critical environments including cleanrooms, laboratories, manufacturing suites, central utilities, and process support systems. Develop control strategies and automation architectures for HVAC, chilled water, steam, compressed air, purified water, and environmental monitoring systems. Ensure automation systems comply with GMP, GxP, FDA, ISPE, and 21 CFR Part 11 requirements where applicable. Participate in design reviews, risk assessments, and change control processes. Support lifecycle documentation including URS, FRS, SDS, HDS, and traceability matrices. Design and develop BMS and automation system architectures for HVAC, electrical, lighting, energy management, and integrated building systems. Develop control sequences, points lists, network architecture diagrams, and system specifications. Engineer solutions using platforms such as Siemens, Johnson Controls, Honeywell, Schneider Electric, Tridium Niagara, Distech, Alerton, or similar systems. Review mechanical and electrical drawings to ensure controls compatibility and proper integration. Select appropriate controllers, sensors, actuators, and field devices. Ensure designs comply with project specifications, applicable codes, and client standards. Programming & Integration Develop and modify BMS software, HMI graphics, databases, alarming, trending, and reporting functions. Program and troubleshoot Rockwell Automation PLCs and HMI systems including Allen-Bradley ControlLogix, CompactLogix, FactoryTalk View, and Studio 5000. Integrate BMS, SCADA, PLC, and third-party systems using BACnet, Modbus, OPC, Ethernet/IP, and MQTT protocols. Support integration between facility automation systems and manufacturing/process equipment. Configure network communications and troubleshoot interoperability issues. Develop secure and scalable automation solutions aligned with OT cybersecurity best practices. Support data integrity and audit trail requirements in validated environments. Develop and modify BMS software, graphics, databases, alarming, trending, and reporting functions. Program DDC controllers and integrate third-party systems using BACnet, Modbus, LonWorks, OPC, MQTT, or other industry protocols. Configure network communications and troubleshoot interoperability issues. Develop custom control logic and optimization routines. Support cybersecurity hardening and secure remote access solutions. Commissioning, Validation & Startup Lead commissioning, startup, and qualification activities for BMS and automation systems. Execute and support validation deliverables including

IQ/OQ/PQ

protocols and turnover packages. Perform point-to-point checkout, functional testing, SAT/FAT support, and system verification. Troubleshoot hardware, software, networking, and field instrumentation issues. Support deviation investigations, CAPA actions, and change control implementation. Ensure systems meet validated state and compliance expectations. Optimize system performance for reliability, compliance, energy efficiency, and operational continuity. Lead system commissioning activities, point-to-point checkout, functional testing, and validation. Troubleshoot hardware, software, network, and field device issues. Optimize system performance for occupant comfort, energy efficiency, and operational reliability. Support retro-commissioning and system upgrades. Prepare and execute commissioning documentation and test scripts. Required Qualifications Bachelor s degree in Electrical Engineering, Mechanical Engineering, Controls Engineering, Automation Engineering, or related technical field; equivalent experience may be considered. 7+ years of experience in building automation, industrial automation, or controls engineering. Experience working in GMP/GxP-regulated pharmaceutical, biotech, life sciences, or advanced manufacturing environments. Strong knowledge of HVAC systems, critical utilities, cleanroom environments, and building controls. Hands-on experience with validation and qualification activities including

IQ/OQ/PQ

documentation. Experience with Rockwell Automation platforms including Allen-Bradley PLCs, ControlLogix, CompactLogix, FactoryTalk, and Studio 5000. Experience programming and commissioning BMS/DDC systems. Strong understanding of industry communication protocols including BACnet, Modbus, OPC, and Ethernet/IP. Familiarity with FDA regulations, 21 CFR Part 11, data integrity, and change control processes. Ability to read and interpret P&IDs, electrical drawings, control schematics, and sequence of operations. Excellent troubleshooting, analytical, and communication skills. Ability to travel to project sites as required. Thanks & Regards Shivam Rajpal Team Lead

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