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.
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
The Principal Quality Engineer (Advanced Analytics & Design to
- Handle the development, documentation and deployment of methods
that utilize science, engineering, risk and statistics to support informed
- 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
- Ensure/drive internal consistency in nature of relationships and
interactions with project teams.
- Develop and deliver training for statistical methods (virtual and
- 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
- 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.
- 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
- 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
- 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
United States-New Jersey-RaritanOther 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-BeerseOrganization
JANSSEN SUPPLY GROUP, LLC (6046)Job Function