Engineer II, Plant
- Research Triangle Park, NC
- Department: Manufacturing
- Region: US
About This Role
The Plant Engineer II is responsible for support of both GMP and non-GMP utility systems at a pharmaceutical manufacturing site. The role requires engineering technical support and troubleshooting for clean utilities, plant utilities, environmental chambers (incubators, refrigerators, freezers), waste systems and process gasses. It also includes involvement in identifying and executing improvements to equipment including support for design, construction and commissioning work on capital and operational projects. Projects can include the installation of plant utility equipment required for new capabilities as well as modifications to existing equipment. Position requires the ability to contribute to multi-function teams to implement change and improve on existing engineering design, construction, and commissioning processes. The ideal candidate can manage small to medium engineering projects with some direction including working with and providing direction to contractors. The role is part of a diverse Plant Engineering team of 4 to 6 Engineers and requires excellent verbal and written communication skills along with organizational and time management skills.
What You’ll Do
- Provide Plant Engineering support to utilities operation including: monitoring and analysis of system performance, investigation of equipment failures and development of operational enhancements, as well as identification and implementation of continuous improvement projects for Plant Engineering systems,
- Perform on-boarding, retiring and engineering technical support for GMP environmentally controlled chambers, freezers, and refrigerators, including management of change control documentation and coordination with small cross-function teams.
- Provide project management and execution for small OpEx projects and work with other Plant Engineers to support larger OpEx projects
- Provide engineering representation and support on large capital projects involving Plant Engineering equipment and systems.
- Participate in startup activities & commissioning for new and modified systems.
- Support GMP compliance efforts including managing change control documentation, personal training, GMP document development, compliance workflow tracking, & regulatory audit support, as needed.
Who You Are
You are an energetic and technical person interested in learning a wide range of Engineering systems in a collaborative environment where your work can help deliver life-changing therapies to patients around the world. You have effective communication and collaboration skills for working cross functionally to assure objectives are met. You are someone who can follow standard practices, processes, and procedures; participate in key strategic initiatives; and identify potential improvements for utility and facility systems as part of a dynamic team.
- Bachelor’s Degree in Engineering
- 2+ years supporting plant engineering systems in pharmaceutical or biotech manufacturing environment.
- Engineering experience supporting some of the following equipment: air handlers, clean rooms, compendial water systems, clean steam systems, and clean gas systems. Prefer GMP facility experience.
- Experience with non-GMP utility systems including plant steam, hot water skids, glycol and tower/chilled water systems
- Familiarity with operation and troubleshooting of PLC (Programmable Logic Controllers), automation and electrical systems.
- Experience with documentation requirements for GMP manufacturing facilities including Change Control and Validation systems.
- Ability to occasionally work rotating shifts, extended shifts and weekends as needed to support projects or on-call issues.
- Master’s or advanced degree in Engineering
- 1+ years in pharmaceutical or biotech manufacturing environment.
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.