Engineer - Concord, CA | Biospace
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Engineer

Cerus Corporation

Location:
Concord, CA
Posted Date:
12/1/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Engineering,

Job Description

Provides engineering and laboratory support for the Class III INTERCEPT Blood System for Platelets, Plasma, and Red Blood Cells.   This position is focused primarily on the single-use INTERCEPT Processing Sets and components thereof.   The scope of this position will include new product development, product and quality improvements, supply chain assurance, and margin expansion projects.  

Primary Responsibilities:

•   Independently design, execute, and analyze data from manufacturing and laboratory experiments or studies.
•   Perform and appropriately document GLP, GMP, and notebook study chemical and physical integrity testing of products and packaging.
•   Build in-house capability by validating new laboratory test methods.
•   Participate in product improvement and ongoing supply assurance/cost savings projects for commercial INTERCEPT products.
•   Participate on cross-functional project teams providing contribution of ideas, developing of plans, execution of plans, and timely reporting of results.
•   Participate in meetings and interactions with suppliers, contract manufacturers, and external testing laboratories.
•   Prepare and manipulate various blood products, including plasma, platelets and RBC.
•   Release new or revise existing documentation into the Cerus Document Control System.
•   Perform other related duties as required.  

Requirements

•   Bachelors or Master’s degree in chemical, mechanical, or biomedical engineering with a minimum of 2 years’ experience.
•   Must have previous experience working in a chemistry or life sciences laboratory.
•   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 (< 15%).