|Date Posted||March 10, 2021|
|Address||PO Box 158|
Scientific Protein Laboratories is a biopharmaceutical leader in the development and manufacturing of cGMP-compliant products including pancreatic enzymes and heparin. Lately, SPL has embarked in a new direction of expanding and diversifying its product portfolio and pipeline by actively investing in new technologies and products including both external partnerships and internal development efforts. We have an immediate opening in Waunakee, WI (Madison area) for a Sr. Project Engineer of Specialty Products to join our growing R&D Specialty Products Business team.
This position is responsible for scale-up and implementing biopharmaceutical manufacturing projects while maintaining cGMP compliance. The Sr. Project Engineer provides engineering guidance and leadership for manufacturing planning and development activities, including new and existing specialty products and external contract development projects. This role is responsible for providing engineering and process information in support of Production, Quality and Sales and Marketing department needs. The Sr. Project Engineer of Specialty Products reports to the Director of Specialty Products Business.
Duties and Responsibilities
- Lead and facilitate transition of new product processes from development to manufacturing. Perform process scale-up, specify new equipment, work with outside equipment vendors, prepare mass and energy balances, analyze processes, and prepare process flow diagrams.
- Prepare timelines, identify resource requirements, plan and schedule production campaigns and facility/equipment utilization for contract manufacturing projects.
- Provide engineering leadership in the operation and cGMP compliance of the R&D/Specialty Products department laboratories and manufacturing facilities.
- Interact with Specialty Products Business customers on aspects of contract development and manufacturing projects.
- Prepare reports, protocols, SOPs, equipment instructions, and other engineering and manufacturing documents in support of development, scale-up, manufacturing, and operations activities as required.
- Coordinate with SPL Project Engineering on larger capital projects.
- Order equipment and supplies required by production, perform general lab maintenance which is required of all R&D employees.
- Bachelor’s or Master’s Degree in chemical engineering is required
- Minimum 5+ years of experience. 10+ years of experience preferred
- Must have working knowledge and hands-on skills related to process design, development and scale-up, and equipment operation.
- Demonstrated experience in pilot scale cGMP or other regulated industry operation is highly desirable.
- Demonstrated proficiency in Process Engineering methods and techniques.
- Experience in a pharmaceutical manufacturing and/or research setting is preferable.
- Experience with new industry guidance and regulations is highly desirable.