Senior Controls Engineer - Operational Technology (Durham, NC)
Unither Pharmaceuticals
Summary
You’ll bring automation and controls expertise to a role where complex systems, advanced technology, and operational excellence come together. You’ll play a hands‑on role in keeping the systems behind life‑saving therapies running safely, reliably, and intelligently. In this role, you will provide key advanced technical and automation support for complex distributed control systems, packaging automation and manufacturing automation systems, including Schneider EcoStruxure, AVEVA (WW) Archestra, and JCI Metasys in a regulated, validated environment. In addition, the Senior Controls Engineer will provide power management systems, building lighting systems and energy management support.
Job description
- Provide key complex support of distributed control systems, packaging and manufacturing automation systems to optimize costs, quality and service through the conception, development and implementation of new and improved manufacturing processes, equipment, tooling, material flow, plant layout or product design, including but not limited to:
- Perform advanced application trouble shooting, architecture review, system staging, and consulting services;
- Troubleshoot and maintain PLCs, HMIs, and field devices under strict change control;
- Perform complex network troubleshooting, database troubleshooting, SQL programming and repair programming;
- Perform preventative maintenance procedures on system and/or equipment;
- Collaborate with the engineering team on the system configuration, network and software requirements, graphics, programming, and sequences of operations;
- Ensure PLC specifications, designs, programming standards and implementation and verify those standards are being met;
- Ensure GAMP/cGxP procedures and testing implementation are being adhered to
- Provide advanced system support for Operational Technology systems to include Enterprise Quality Management System (TrackWise), Enterprise Resource Planning (ERP) Systems (SAP), Electronic Document Management Systems (EDMS) (Adept and MasterControl), and Electronic Batch Records (EBR).
- Perform other duties as assigned
Requirements
- H.S. Diploma or General Education Degree (GED) and 9+ years of automation experience across multiple systems, or
- Associate degree and 7+ years of automation experience across multiple systems, or
- Bachelor’s degree and 5+ years of automation experience across multiple systems
- Experience as controls / automation subject matter expert for construction or other projects
- Prior experience working in an FDA regulated pharmaceutical manufacturing or other FDA regulated manufacturing environment
- Programming/design/development of Rockwell/Allen Bradley, Control Logix, RSLogix, Compact Logix, FactoryTalk Batch, Siemens S5 & S7 PLC's, RSView, FactoryTalk View, PanelView, Wonderware, or related
- Schneider EcoStruxure, AVEVA (WW) Archestra, and JCI Metasys experience
- Superior database maintenance / development experience
- Computer hardware / software validation and change control experience
- PLC programming and connectivity experience
- Industrial networking experience
- Experience working in small, fast paced project teams
- Organizational skills including, but not limited to, the ability to handle multiple demands and assignments, the ability to prioritize tasks effectively and efficiently, and the ability to effectively manage resource procurement and utilization
- Ability to work under pressure and adhere to deadlines
- Experience developing engineering documentation (URS/DDS/FDS/P&IDS)
Benefits
- Medical, Dental & Vision
- Prescription Coverage
- Employee Wellness Resources
- 401(k) Savings Plan
- Employee Stock Purchase Plan
- Paid Time Off
- Paid Parental Leave
- Disability Benefits
Company overview
Unither Pharmaceuticals is a world-leading pharmaceutical contract development and manufacturing organization (CDMO) specializing in sterile and non-sterile liquid dosage forms. Founded in 1993 and headquartered in Paris, France, the company has established itself as the global leader in Blow-Fill-Seal (BFS) technology for sterile unit-dose manufacturing. With eight manufacturing plants across France, the United States, Brazil, and China, plus four commercial offices and one R&D platform, Unither operates on four continents and distributes products to over 100 countries. The company employs approximately 2,000 professionals and generates annual revenues of €371 million. Unither's core expertise includes innovative technologies such as Liquid Stick-Pack, sterile unit-dose BFS technology, multidose formulations with and without preservatives, pharmaceutical bottles, suppositories, and pessaries. As a pure-player CDMO, Unither offers comprehensive services from early-stage development to commercial manufacturing, focusing on making affordable healthcare solutions that simplify patients' lives while delivering innovative, competitive, and sustainable solutions to pharmaceutical partners worldwide.