Application Programming Interface (API), Automation, Biotech and Pharmaceutical, Code of Federal Regulations, Commissioning, Computer Science, Control Engineering, Control Systems, Documentation, Electricity, Electronics, English Language, Gene Therapy, Maintain Compliance, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Problem Solving Skills, Process Validation, Programmable Logic Controller (PLC), Project Tracking, Project/Program Coordination, Quality Management, Regulatory Requirements, Safety/Work Safety, Software Development, Software Engineering, Software Specification, Systems Engineering, Team Player, Time Management, Willing to Travel
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)
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
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Sterling Engineering, Inc.
Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:
- Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.
- Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.
Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.
500 to 999 employees
Staffing/Employment Agencies
http://www.sterling-engineering.com