- Title: Cost Engineer
- Code: RCI-02960
- Location: Chattanooga Tennessee (TN) 37408
- Posted Date: 09/18/2020
- Duration: 5 Months
- Name:Ankit Shah
- Email: Ankit.Shah@rangam.com
- Phone: 908-704-8843 ✖ 210
This role will be a mix of remote and onsite. Long term, the role is an onsite position.
Responsible for leading commercial product support, scale-up/validation activities, and providing plant technical support. Duration is November ’20 through April ’21.
- Lead Quality by Design, Scale-up, and Validation projects for over-the-counter product launches and process optimizations
- Lead equipment and cleaning requalification reviews to ensure equipment and processes remain in a validated state.
- Design and execute batch record creation and modifications
- Create and execute Validation Protocols and issue reports to qualify new processes or process optimizations
- Execute process improvement initiatives to improve compliance and efficiency
- Manufacture pilot feasibility and stability batches to support scale-up for new product launches
- Perform bench scale work to understand and determine critical processing parameters
- Develop strategies for execution of process, packaging, equipment, and cleaning validations
- Generate and analyze statistical data to support validation protocols, investigations, and annual validation reviews
- Support deviations and incident investigations related to pilot, validation, and plant activities
- Provide technical support for Plant Operations
- 1-3 Year science or engineering degree minimum; Chemistry or Engineering degree
- Experience in a drug/OTC GMP Manufacturing environment
- Product formulation and processing experience.
- Strong technical writing skills.
- Attention to detail. Ability to work with a variety of groups (Operations, Engineering, Quality).
- Ability to manage multiple projects at one time.
- Independently action-oriented
- Strong analytical skills with ability to analyze problems, identify key issues, and develop strategic and tactical solutions