Controls Engineer II, Operational Technology / Senior Controls Engineer, Operational Technology (Silver Spring, MD)
Unither Pharmaceuticals
Summary
You’ll play a hands-on role in keeping the systems behind life-saving therapies running safely, reliably, and intelligently. In this role, you’ll support and troubleshoot complex manufacturing automation and distributed control systems—working with PLCs, HMIs, networks, and validated OT platforms in a highly regulated environment where precision matters. The Controls Engineer II, Operational Technology will provide key technical and automation support for complex distributed control systems and manufacturing automation systems, including Schneider EcoStruxure, AVEVA Archestra, and JCI Metasys in a regulated, validated environment.
Job description
- Provide key support of distributed control systems and manufacturing automation systems
- Perform system and equipment troubleshooting
- Troubleshoot and maintain PLCs, VFDs, HMIs and field devices under strict change control
- Perform preventative maintenance procedures on system and/or equipment as required
- Perform network troubleshooting, database troubleshooting and repair programming
- Ensure PLC specifications, designs, programming standards and implementation and verify those standards are being met
- Ensure GAMP/cGxP procedures and testing implementation are followed
- Provide system support for Operational Technology systems to include Enterprise Quality Management System (TrackWise), Enterprise Resource Planning (ERP) Systems (SAP), and Electronic Document Management Systems (EDMS) (Adept and MasterControl)
- Perform other duties as assigned
Requirements
- H.S. Diploma or GED and 6+ years of automation experience, or Associate degree and 4+ years of automation experience, or Bachelor’s degree and 2+ years of automation experience (Controls Engineer II level)
- H.S. Diploma or 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 (Senior Controls Engineer level)
- Prior experience working in an FDA regulated pharmaceutical manufacturing or other FDA regulated manufacturing environment
- Organizational skills including ability to handle multiple demands and assignments, prioritize tasks effectively, and manage resource procurement and utilization
- Superior database maintenance / development experience
- Computer hardware / software validation and change control experience
- PLC programming and connectivity experience
- Industrial networking experience
- Experience with Schneider EcoStruxure, AVEVA Archestra, and JCI Metasys
- Experience working in small, fast paced project teams
- Ability to work under pressure and adhere to deadlines
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.