Plan and execute complex engineering projects to improve product quality, increase operating performance, and add process capability to the plant. Those projects will consist of the development and support of manufacturing processes and procedures, tools and equipment, layouts, and methods.
The incumbent interacts with both internal customers and external vendors. That interaction requires good communication, both oral and written, and keen analytical skills in identifying problems and implementing engineering solutions. Effectiveness in this role also requires a good technical and functional understanding of the assigned customers’ products, processes, equipment, and systems. The incumbent will need to apply fundamental engineering concepts, practices and procedures to solve problems and create solutions. The role will provide continuous development of technical expertise through experience and application. That expertise will be used to help guide more junior engineers in their design and troubleshooting efforts. The incumbent works on complex problems of moderate scope, requiring analysis of identifiable factors. The incumbent will exercise judgment within well-defined procedures.
- Significant travel required for first year for training
- Direct the troubleshooting of existing products and processes to recommend and develop/design engineering solutions and/or equipment to address capacity, cost, and quality issues.
- Drive Continuous Improvement initiatives and support Practical Process Improvement (PPI) activities.
- Act as Project Engineer to lead, plan, and execute projects.
- Evaluate economic feasibility of capital projects and prepare justifications. Participate on project teams to develop and execute project plans.
- Independently performs design and development of new, complex products and processes. May lead engineering design teams.
- Proactively interface with internal departments to develop engineering specifications and plans.
- Primary engineering resource on New Product Introduction teams in the transfer and scale-up of new products and processes.
- Identify and implement new equipment to meet product and process requirements
- Develop and conduct new validation/qualification methods and protocols for new products, processes, and systems.
- Understand, support, and utilize 6 sigma and Lean Manufacturing tools.
- Collect and analyze data using engineering principles and statistical models and interpret results; independently plan and design experiments.
- Prepare reports and present data to peers, supervisor, and internal customers.
- Generate and maintain project documentation as required, including: Timelines, Risk Assessments, Drawings, Schematics, SOPs, Piping and Instrumentation Diagram (P&IDs)
- Perform all job duties within ISO standards.
- May perform other related duties as required and/or assigned.
- Bachelors or Master’s degree in Chemical Engineering, Mechanical Engineering, Biochemical, Bioengineering, or related field required.
- Requires BS 5-10 years or MS 2-5 years with relevant engineering experience
- Knowledge of relevant biotechnology processes, manufacturing systems, and products required.
- Excellent communications and analytical skills needed. Familiarity of relevant regulatory requirements preferred.
- Ability to work with all levels of company employees.