Principal Quality Engineer (Advanced Analytics & Design to Value)
Location:
Malvern , Pennsylvania
Posted:
January 27, 2017
Reference:
000018FL/3-en-us

Janssen Supply Group, LLC is recruiting for a Principal Quality Engineer, Advanced Analytics (AA) & Design to Value (DtV).  The preferred locations for this position are in: Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; or Schaffhausen, Switzerland, but considerations will also be made for the following sites: Malvern, PA; Horsham, PA; Cork, Ireland; Leiden, Netherlands.

 

Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world.  With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.

 
Position Overview:
 

The Product Quality Management (PQM) Advanced Analytics (AA) & Design to Value (DtV) Principal Quality Engineer is responsible for leading AA & DtV systems improvement throughout the Global Pharma Quality organization, including: device, drug and combination products. He or she will drive the Informed Decision Making initiative throughout Pharmaceutical Development and Manufacturing Science (PDMS) and Janssen Supply Chain (JSC). The incumbent will perform the following activities: development of methods for Informed Decision Making, deployment of projects related to cost and quality, and approval as well as execution of statistical analyses.  The position requires experience with combination products.

 

The Principal Quality Engineer (Advanced Analytics & Design to Value) will:

 
  • Handle the development, documentation and deployment of methods that utilize science, engineering, risk and statistics to support informed decision making.
  • Provide direction in the use of applied statistics for the Global Pharma Quality organization.
  • Working with global functions and sites to deploy continuous improvement and cost reduction initiatives using the application of Informed Decision Making, Quality and Quality by Design principles.
  • Represent the Global Pharma Quality organization as a Subject Matter Expert for statistical analysis.
  • Escalate DtV and Combination product issues related to statistical methods to Quality Management (QM)
  • Assist with DtV and Combination product related regulatory visits, corporate audits and vendor audits and provide follow up on regulatory commitments.
  • Ensure/drive internal consistency in nature of relationships and interactions with project teams.
  • Develop and deliver training for statistical methods (virtual and in person). 
  • Provide support to JSC in defining, collecting, and analyzing Quality Metrics such as Best Practices, Design to Value progress metrics and Implementation of dashboard tools.
  • Apply intensive and diversified knowledge of statistics to broad areas of the Janssen Supply Chain decision making processes.  (including; DtV, AA, Design Controls, Process Validation and Supplier Management).
  • Plan, develop, coordinate, and direct global initiatives as well as a number of sub-projects with many complex features.
  • Contribute to the development of new or improved techniques or procedures related to the statistical tools and business processes used within JSC.
  • Develop and evaluate plans and criteria for a variety of projects and activities to be carried out by others.
  • Provide structure, direction, decision making and leadership to project team members.   
  • Collaborate with all stakeholders and business partners to meet goals and objectives, identify opportunities and drive projects forward. 


Qualifications
  • A combination of the following education and experience is required: Bachelor’s Degree with a minimum of 9 years related experience in the medical device, pharmaceutical or biopharmaceutical industry OR a Master’s degree with a minimum of 7 years related experience in medical device, pharmaceutical or biopharmaceutical industry OR a PhD with a minimum of 5 years related experience.
  • A degree in Statistics, Chemistry, Biology, Engineering, or other scientific discipline is highly preferred.
  • Experience with Quality Systems, cGMP, and ICH Requirements is required
  • A strong background in Engineering is preferred.    
  • Experience in a regulated industry required. 
  • Strong statistical skills are highly preferred. 
  • Project management training or experience highly preferred.
  • Excellent technical writing skills; experienced in writing SOPs, protocols, reports required
  • Master Black Belt or Black belt certification is preferred.
  • Experience in technology transfer/design transfer preferred.
  • Knowledge of Biotech and/or Pharma Manufacturing preferred.  
  • Prior participation in cross functional projects preferred.
  • Knowledge and experience with Bayesian methods preferred.
  • Knowledge of QbD, basic manufacturing processes, LEAN, basic automation/IT/lab systems development (i.e., design of experiments) and test processes preferred.
  • The preferred locations for this position are in: Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; or Schaffhausen, Switzerland, but considerations will also be made for the following sites: Malvern, PA; Horsham, PA; Cork, Ireland; Leiden, Netherlands.
  • This position may also require up to 25% domestic and international travel. 


Primary Location
United States-New Jersey-Raritan
Other Locations
North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Ireland-Cork-Cork, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality (Eng)

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