Controls Engineer

Control Systems Software Engineer

Location: North America (mostly Indiana)

Employment Type: Direct Hire

Pay: $40-45/hr OT after 45 hours

Travel: ~30% domestic

Overview

We are seeking a Control Systems Software Engineer to provide programming and commissioning support for equipment across North America. This role focuses on software aspects including Siemens & Rockwell PLC/HMI, PCs, and controls software.

Bonus: Pharma experience and knowledge of 21 CFR Part 11 compliance.

Key Responsibilities

Software Development & Project Support

• Develop software per project specifications
• Participate in SAT, IQ/OQ, and PQ for new installations
• Support Radiopharma, Pharma, and Cell & Gene Therapy (ATMP) projects
• Draft and maintain project documentation
• Monitor project objectives and team performance
• Contribute to network architecture and component selection
• Conduct testing, FAT, and on-site commissioning
  
  

Project & Quality Management

• Verify job-critical issues and project timelines
• Solve technical problems and request resources as needed
• Ensure product compliance with internal and international standards
• Assist colleagues in documentation and regulatory compliance
• Other duties as assigned
  
  

Health, Safety & Environment

• Follow all HSE procedures
• Use proper PPE and report unsafe conditions
• Participate in HSE training and incident investigations
  
  

Projects You’ll Work On

Radiopharma

• Shielded hot cells, automation systems, synthesis/dispensing modules
• LAF shielded isolators, sterilization systems
  
  

Pharma

• Aseptic filling of liquid/powder APIs
• Potent API processing isolators (PAPI)
• Automated combination product filling systems
  
  

Cell & Gene Therapy (ATMP)

• Modular cell culture isolators (MCCI)
• FlexyCult™ incubation systems, ValueCell Fill systems
  
  

Qualifications

• Bachelor’s degree or post-secondary in Automation, Computer Science, Electrical, or Electronics
• 3 years in controls engineering software
• PLC knowledge: Siemens (TIA Portal, Step7), Rockwell, B&R
• SCADA/HMI: Siemens WinCC, Movicon, Rockwell, B&R
• Familiarity with regulatory requirements and certification processes
• Strong teamwork, time management, and project coordination
• Self-driven, detail-oriented, process-focused
• Fluent in English; Italian is a plus
• Proficient with Outlook, Project, Word, Excel, PowerPoint
• Able to travel domestically & internationally within 30 days of hire
  
  

Physical Requirements

• Stand, walk, push/pull, reach overhead, bend
• Normal vision and hearing for office/computer work
• Exposure to noise/physical hazards at customer sites