Controls Engineer
Scientific Protein Laboratories
Summary
The Controls Engineer is responsible for the development, maintenance, and troubleshooting of PLC and HMI programs for production and utility systems in a cGMP pharmaceutical manufacturing environment. This role requires meticulous attention to detail, strict adherence to programming standards (including ISA-88/S88 batch control standards), and thorough documentation practices to ensure compliance with FDA 21 CFR Part 11, data integrity requirements, and validation protocols. The Automation Engineer will focus primarily on Rockwell Automation platforms including ControlLogix, CompactLogix, PlantPAx, and FactoryTalk View SE applications. This position works cross-functionally with Production, Quality, and Engineering teams to optimize automated systems and advises on automation requirements for capital improvement projects.
Job description
Responsibilities
- Develop, maintain, and troubleshoot PLC programs using Rockwell Automation ControlLogix and CompactLogix platforms in compliance with cGMP and FDA 21 CFR Part 11 requirements
- Design, program, and maintain HMI applications using Rockwell FactoryTalk View Site Edition (SE), ensuring strict adherence to data integrity principles (ALCOA+)
- Program and maintain PlantPAx distributed control system applications following ISA-88 (S88) batch control standards and established programming conventions
- Create and maintain accurate, revision-controlled program documentation including functional specifications, code comments, and change logs per pharmaceutical industry standards
- Document all automation work activities, troubleshooting outcomes, and system modifications in the CMMS (Fiix) to maintain comprehensive equipment history records
- Implement and validate control system modifications following established change control procedures and validation protocols (IQ/OQ/PQ)
- Troubleshoot and resolve automation system issues in a timely manner to minimize production downtime while maintaining complete documentation of all actions taken
- Collaborate with Production, Quality, and other departmental teams to identify, optimize, and resolve pain points with automated system operations
- Support process validation activities by programming recipe-based batch control systems and ensuring audit trail functionality
- Collaborate with Quality Assurance to ensure all automation changes meet regulatory requirements and pass internal/external audits
- Advise Project Engineers on automation requirements for capital projects, including recommendations for large-scale improvements, PLC hardware upgrades, and HMI system enhancements
- Maintain revision control of all PLC and HMI programs using established version control practices
- Develop standardized programming templates and reusable code modules following S88 and internal programming standards to ensure consistency across production systems
- Support maintenance technicians with troubleshooting guides and technical documentation for automated systems
- Participate in root cause analysis for automation-related deviations and implement corrective actions with appropriate documentation
Additional Responsibilities
- Support capital projects involving automation system installations and upgrades
- Capital project execution, including design, specifications, vendor coordination, commissioning, and turnover
- Assist with network infrastructure maintenance for industrial control systems
Requirements
- Associate degree in Industrial Automation, Electronics Technology, Instrumentation, Computer Science, or related technical discipline
- 3+ years of hands-on PLC and HMI programming experience with Rockwell Automation platforms (ControlLogix, CompactLogix, FactoryTalk View SE)
- Proficient in Rockwell Studio 5000/RSLogix 5000 for PLC programming (Ladder Logic, Structured Text, Function Block)
- Proficient in FactoryTalk View Site Edition (SE) for HMI development
- Understanding of industrial networking (EtherNet/IP, DeviceNet)
- Experience documenting work activities and equipment history in a CMMS
- Bachelor’s degree in Computer Science, Engineering Technology, or related discipline
- 5+ years in pharmaceutical, API, or FDA-regulated manufacturing environment
- PlantPAx DCS programming and configuration experience
- Experience with FactoryTalk Historian and FactoryTalk Batch
- Knowledge of FDA 21 CFR Part 11 compliance and data integrity requirements (ALCOA+)
- Experience following ISA-88 (S88) batch control programming standards
Benefits
- Medical, Dental & Vision
- Life & AD&D Insurance
- Short & Long-term Disability
- Health & Flexible Saving Accounts
- Employee Assistance Program
- Generous Vacation
- Paid Holidays
- 401(k)
- Advancement Opportunities
- Team-oriented Environment
- Community Involvement
- Company Events
Company overview
Scientific Protein Laboratories (SPL) is a leading global supplier of high-quality active pharmaceutical ingredients (APIs) with over four decades of experience in the pharmaceutical manufacturing industry. Founded in 1976 in Waunakee, Wisconsin, the company specializes in cGMP biopharmaceutical manufacturing and is among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. SPL serves pharmaceutical, veterinary, and food industries worldwide, operating manufacturing facilities in both Waunakee, Wisconsin and Sioux City, Iowa. The company focuses on extracting, isolating, and purifying naturally-derived materials from animal and plant sources, with particular expertise in porcine-sourced starting materials. As a subsidiary of Shenzhen Hepalink Pharmaceutical since 2014, SPL maintains a strong commitment to regulatory compliance and quality assurance, operating strictly in accordance with FDA's cGMP requirements while providing comprehensive regulatory support to its global customer base.