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Validation Lead II
Ref No.: 15-03817
Location: Swiftwater,, Pennsylvania
 Sanofi Pasteur's Viral Technology Group requires an individual to assist with project responsibilities including authoring documents, and assisting in process development, GMP clinical, and process validation activities for Influenza Drug Substance. Expertise in other disciplines is a plus such as cleaning, filters, and extractables and leachables.
 
Scope of Work:
The candidates will be expected to perform the following type of activities.
 
Technical writing & Write protocols, reports, and other documents are required by the project in order to meet overall project goals. 15 % Data extraction and analysis. 30 % Field Execution. Provide support, coverage, and guidance for manufacturing personnel with field execution activities. – 35 % Various activities in support of the project team. 20 % Individual must have working knowledge of CQA and CPP for biologic or manufacturing sites.
 
Skills:
Biologics process and/or biochemistry knowledge is a big plus.
The ability to work occasional multiple shifts (12 hour shifts) and weekends.
Ability to work well with large diverse groups in multi-functional teams.
Technical writing experience.
Ability to use Excel, Word and PowerPoint is a must; TrackWise change controls and eDoc (document database), a plus.
Ability to manage multiple activities with challenging timelines.
Ability to be self directed in a large organization within a minimal time frame.  Be creative and work through issues independently, where possible.
Excellent communication skills.  The individual must posses the following communication skills:
 
The ability to communicate with employees of all experience levels both from Sanofi Pasteur and other contract firms.
The ability to report on project activity in a clear and concise manner.
The ability to communicate project issues in a manner that leads to resolution.
The ability to communicate with fellow project team members.  The ability to negotiate, when necessary, and compromise with other project team representatives to achieve project goals.
The ability to listen and respect fellow project team member's ideas and opinions and work through conflict and disagreements. 
 
Education: BS/MS Life Science, Bio Engineering or Chemnical Engineering