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Position- Senior Validation Engineer, Local
Type- ONSITE
Location- Lebanon, IN
Visa- GC
Key Responsibilities
Shivam Rajpal
Team Lead- US IT Recruitment
Desk- X 106
Email-
LinkedIn-
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.
- 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.
- 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.
- 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.
Shivam Rajpal
Team Lead- US IT Recruitment
Desk- X 106
Email-
LinkedIn-