Sr Deviation Investigations Engineer

Purpose and scope of position:

• The Senior Scientist/QA Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations.
• The Sr. role will be assigned more complex deviation investigations, and often need to create and facilitate teams to execute all elements in a timely matter.
• Deviation investigation includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA) and troubleshooting complex problems.
• The successful incumbent must interface closely with different functional organizations and management, including Quality Assurance teams.

Education and experience:

• Requires a bachelor’s degree in science or engineering, preferably
• in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
• Minimum 5 years of relevant work experience, preferably in a health authority regulated environment.
• Sr Level requires demonstrated capability in medium and high-risk deviation reports or equivalent proven experience
• Previous experiences working in a biopharmaceutical manufacturing facility and an aseptic environment is preferred (CAR T a plus).
• An equivalent combination of education and experience may substitute.