Lead Controls Engineer, Operational Technology

United Therapeutics•Rtp, NC

2d•Onsite

About The Position

United Therapeutics (Nasdaq: UTHR) is the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. We seek to develop treatments for rare, deadly diseases. Founded in 1996, we now have six FDA-approved therapies. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). We are also working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant, believing an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases. The Lead Controls Engineer will provide expert knowledge, guidance, and leadership in the design, implementation, and support of complex distributed control systems, manufacturing and packaging automation systems, and environmental monitoring systems including Schneider EcoStruxure, AVEVA (WW) Archestra, and Elpro in a regulated, validated environment. This role will provide leadership and guidance to the Operational Technology Automation team, participate in and lead projects as a subject matter expert in automation systems for upgrades and/or new implementations, and provide expert support of distributed control systems, manufacturing and packaging automation systems, and environmental monitoring systems. Responsibilities include troubleshooting and maintaining PLCs, HMIs and field devices under strict change control, performing preventative maintenance procedures on systems and/or equipment as required, and performing network troubleshooting, database troubleshooting, and code troubleshooting and revisions. The role also involves collaborating with engineering, manufacturing, information technology, and validation teams on system configuration, network architecture, software requirements, graphics, programming, and sequence of operations. Additionally, the Lead Controls Engineer will review automation system specifications, programming standards and implementation plans, and verify standards are met, ensuring GAMP/cGxP procedures and testing are followed.

Requirements

Bachelor’s Degree in engineering or information technology.
Minimum 8 years of automation experience including PLC programming and connectivity, Industrial Networking and Schneider EcoStruxure, Wonderware Archestra, and Elpro Environmental Monitoring
Prior experience working in an FDA regulated pharmaceutical manufacturing environment
Prior experience working on construction projects
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
Superior database maintenance / development experience
Computer hardware / software validation and change control experience
PLC programming and connectivity
Industrial Networking
Schneider EcoStruxure, AVEVA (WW) Archestra, and JCI Metasys
Experience working in small, fast paced project teams; ability to work under pressure and adhere to deadlines

Nice To Haves

2+ years of supervisory experience
Portfolio Management Professional (PMP)

Responsibilities

Provide expert knowledge, guidance, and leadership in the design, implementation, and support of complex distributed control systems, manufacturing and packaging automation systems, and environmental monitoring systems.
Provide leadership and guidance to the Operational Technology Automation team.
Participate in and lead projects as a subject matter expert in automation systems for upgrades and/or new implementations.
Provide expert support of distributed control systems, manufacturing and packaging automation systems, and environmental monitoring systems.
Troubleshoot and maintain PLCs, HMIs and field devices under strict change control.
Perform preventative maintenance procedures on systems and/or equipment as required.
Perform network troubleshooting, database troubleshooting, and code troubleshooting and revisions.
Collaborate with engineering, manufacturing, information technology, and validation teams on system configuration, network architecture, software requirements, graphics, programming, and sequence of operations.
Review automation system specifications, programming standards and implementation plans.
Verify standards are met; ensure GAMP/cGxP procedures and testing are followed.