Manufacturing Engineer

Location
94520, Concord
Posted
Jul 30, 2018
Discipline
Engineering
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

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%).

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