Manufacturing Engineer

Location
94520, Concord
Posted
May 29, 2018
Required Education
Bachelors Degree
Position Type
Full time

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.

 Primary Responsibilities:

  • 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

    Qualifications/Requirements/Skills: 

  • 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%).