- Technical expert to drive activities in-house in partnership with Global programs and/or in collaboration with Global projects, other sites, Mtech platforms, and Quality (QPQV, QC-VIMM)/RA/Engineering functions for major activities associated with particulate reduction and prevention in the following areas;
o Program - Lead site continuous improvement program related to particulate prevention, testing and reduction in sterile injectible products
o Quality/regulatory- Technical input and/or gap analysis of internal and external Quality/Regulatory guidelines pertaining to particulate prevention; SME for site during health authority inspection
o Validation- Build and implement Risk based and life cycle approach in particulate control
o Equipment -support design or remediation activities requiring equipment upgrades in partnership with GEM for particulate prevention
o Process -drive design space for new products/processes or remediation activities for existing process steps that contribute particulate or fail to prevent particulates from breaching preventative measures for particulate removal/prevention.
o Facilities - Facilitate Identify/define remediation activities for facilities for particulate prevention.
o Personnel - Facilitate identification/definition remediation activities for inspector calibration, root cause investigations, and training modules identified as a remediation needed for particulate prevention.
o Components- Work with vendor, purchasing, and quality to improve process and control of components manufacturing process and testing
o Testing- Work with internal and external testing laboratories to maintain and evolve standards, methods and data analysis tools
- Participate in activities related to particulate testing and characterization as a part of root cause investigations.
- Technical leader in the field of particulate prevention. Perform in depth evaluation of various factors within multiple areas of expertise and lead activities associated with projects for particulate reduction.
- Represent sanofi pasteur and manufacturing site in external forums to contribute to industry position, facilitate partnership with institution and academia to develop risk.M*
Sanofi Pasteur SA is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment regardless of their race, color, religion, sex, national origin, or any other characteristics protected by applicable law.
- PhD in Sciences, Engineering or Pharmaceutics with emphasis on particles analysis and visual inspection with 5-7 years relevant industrial experience in a similar role.
- MS in Sciences, Engineering or Pharmaceutics with 7-10 years of relevant industrial experience
- BS in Sciences, Engineering or Pharmaceutics with 12-18 years of relevant industrial experience.M*
Sanofi Pasteur - 20 months ago
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