QA Engineer, Drug Product

• 
  Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals
  
• BS in Life Sciences or Engineering plus 8 years of experience in GMP quality assurance or similar role OR a MS degree plus 6 years of relevant GMP QA experience.

• 
  High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies
  
  
  
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11 required

• Working knowledge of ASTM E2500, Smartsheet and/or Kneat validation software is a plus
• Understanding of one or more of the following processes preferred:

• cell culture or fermentation
• large-scale recovery processes
• formulation and/or aseptic filling
• finished goods manufacturing

• Training and/or familiarity with Quality Risk Management principles.

• Occasional opportunity for International and/or Domestic travel may be available

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.