Principal Quality Engineer

Requirements:

  • Strong leadership qualities and embodies Sanofi's core leadership principals 
  • Performs timely and complete QA review and approval of validation lifecycle  documents and determines interrelated impacts to processes and systems 
  • Ensures completeness, timeliness and accuracy of documentation such as engineering studies, validation protocols/non-conformances/reports, technical reports, engineering drawings and MBRs/SOPs  
  • Participate in Community of Practice discussions to share best practices and raise opportunities for simplification and harmonization  
  • Partners with project teams to develop the implementation strategy and change control approach for complex projects with validation impact  
  •  Performs validation assessments for change control requests that comply with Sanofi and Biologics Quality standards, procedures and guidance  
  • Lead and participates in gap assessments against Sanofi and Biologics Quality directives/standards and authors gap remediation plans  
  • Authors or reviews validation section of annual periodic product reviews  
  • Proactively identifies compliance risk and presents to cross-functional site risk review team or quality council, as appropriate  
  • Applies Sanofi Manufacturing System (SMS) tools  
  • Supports external regulatory inspections through consultation with other Subject  
  • Subject Matter Expert and direct interaction with investigators for requests within area of expertise. Leads or supports execution of CAPA for external regulatory commitments.  
  • Participates in formal risk assessments  
  • Demonstrate an ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services.   

Experience:

  • Experience in a regulated, cGXP environment or Master's degree and a minimum of 6 years' experience working in a regulated, cGXP environment  
  • Experience in one or more of the following areas with demonstrated  
  • Knowledge of the validation lifecycle: Quality Assurance, Quality Control, Manufacturing  
  • Technical Support, Facilities Engineering, or Computer Systems/Automation  
  • Knowledge of cGXP regulations and guidance  
  • Excellent technical writing skills  
  • Experience with change control and CAPA quality systems  
  • Experience with LEAN Manufacturing (problem solving/use of LEAN tools) or comparable continuous improvement systems.  
  • Experience with root cause analysis tools and gap identification.  

Education:

Bachelor's degree in Science or Engineering and a minimum of 9 years’ experience  


About us -VIE HIRE   We are not a large corporate consulting conglomerate, we are a small and steadily growing valuable consulting firm. -Valuable to our clients and consultants we work with. We have an excellent reputation with our clients and one that we continue to build upon. We are always looking for top talent.

*** EASY APPLY on our Company Page with RESUME ONLY (Cover page optional) ***

If this role is not a fit for you, and you're actively looking to be considered for work; please email us your resume: HireMe@VIEHIRE.com 

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