Summary & Scope of Position:
Provides engineering and laboratory support for the Class III INTERCEPT Blood System for Platelets and Plasma. This position is focused primarily on the single-use INTERCEPT Processing Sets and components thereof. The scope of this position will include manufacturing product and quality improvements, supply chain assurance, and margin expansion projects.
- Support post-commercialization product/process changes, assembly line optimization, production expansion activities, and cost-saving initiatives at contract manufacturers. Work with contract manufacturers and vendors to prioritize and solve issues.
- Execute and analyze data from manufacturing or design verification studies.
- Work with Quality Assurance and Operations teams to identify, correct, and prevent product quality issues.
- Participate in meetings and interactions with suppliers, contract manufacturers, and external testing laboratories.
- Prepare and manipulate various blood products, including plasma and platelets.
- Perform and appropriately document GLP/GMP and notebook studies.
- Release new or revise existing documentation into the Cerus Document Control System.
- Perform other related duties as required
- Bachelors or Master’s degree in chemical, mechanical, or biomedical engineering.
- Experience working in a GMP manufacturing environment is a plus.
- Familiarity with GLP/GMP regulations & record keeping is a plus.
- Familiarity with manufacturing validation requirements (IQ/OQ/PQ) is a plus.
- Proficient in writing protocols and reports.
- Ability to make decisions on the validity and importance of experimental results, the potential success or failure of activities within their area of expertise.
- Excellent mathematical skills, problem solving skills, and ability to apply scientific methods to resolution. Solid experience with related computer software.
- Strong attention to detail and accuracy.
- Flexible; ability to adapt to changing priorities.
- Solid communication skills (verbal, written, interpersonal, listening).
- Ability to work independently and as part of a team.
- Some travel required (< 25%).