The Specialist, Operational Excellence, supports all site functions at the NC site. This role reports to the Site Operation Manager and serves as the site lead for all operational excellence initiatives at the site as well as collaboration with NTO.
- Identifies, develops and implements process robustness improvements through lean principals.
- Leads lean and six sigma training needs for the site.
- Develops and maintains the operational excellence portfolio of projects/activities for the site.
- Helps establish key metrics, tracking results, and supports the sites ability to perform and deliver to plan.
- Implements value stream mapping, visual control boards and provides ongoing support to each of the sitewide functions.
- Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines.
- Management of multiple projects and timelines concurrently.
- Works on the manufacturing, warehouse and quality lab shop floors for data gathering and observing of processes.
- Supports the Project Management team and participates and assists with the Hoshin Kanri process.
- Ensures process alignment between the manufacturing sites through collaborative interactions with manufacturing, MSAT, QA/QC, engineering and the supply chain functions at both production sites.
- Maintains quality standards to meet GMP requirements, CFR’s and internal company policies with respect to operations.
- Other related duties as assigned.
- B.S. degree in Engineering or the life sciences and 5 years of work experience in lean biopharmaceutical based GMP manufacturing operations.
- In-depth knowledge of FDA regulations and GMP systems and experience providing process support in a highly regulated or pharmaceutical / biotech facility.
- Applied knowledge of value stream mapping, tier structures, six-sigma, lean and operational excellence tools in creating efficient and high-quality processes and end products.
- Ability to facilitate problem solving, work with the shop floor and collaborate with multiple functions for process improvement initiatives.
- Excellent project management, oral and written communication skills.
- Strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills.
- Statistical analysis capabilities.
- Six-sigma green belt or black belt preferred.
- Travel as required to other internal sites, vendors, and CMOs as required (5-15%).