Scientist/Engineer
Company: Axelon Services Corporation
Location: Summit
Posted on: May 28, 2023
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Job Description:
Job Description:
hybrid role
The Scientist/Engineer is responsible for leading manufacturing and
QC investigation reports in support of S12 CAR T operations. This
includes execution of thorough root cause investigations,
interviewing personnel, hypothesis testing and interpretation of
results, authoring investigation reports, identifying corrective
and preventive actions (CAPA), and troubleshooting complex
problems. The successful incumbent must interface closely with
different functional organizations, including Quality Assurance
teams.
REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
" Working experience of deviation investigations utilizing root
cause analysis tools.
" Working experience in the CAPA process and ability to identify
and verify effectiveness.
" Technical writing skills and ability to collaborate effectively
in cross functional teams.
" Proven ability to accurately and completely understand, follow,
interpret, apply Global Regulatory and cGMP requirements.
" Ability to support health authority inspections.
" Knowledge of data trending and tracking, including use of
statistical analysis software a plus.
" Demonstrate advanced problem-solving ability / mentality,
technical adeptness and logical thinking.
" Ability to set priorities, manage timelines and effectively
react/manage changing priorities.
" Ability to work with management (global and site) and support
corporate and departmental goals.
" Ability to communicate honestly, transparently and effectively
with peers, department management and cross functional peers.
" Ability to utilize electronic Quality systems such as eQRMs
(Enterprise Quality and Regulatory Management system).
" Hands on experience preferred with CAR-T or biopharmaceutical
manufacturing and Quality Control.
" Ability to train new team members on the investigation
process
Education and Experience: " Requires a Bachelor s Degree in science
or engineering, preferably in Biochemistry, life sciences or
related engineering discipline (advanced degree preferred).
" Minimum 3 years of relevant work experience, preferably in a
health authority regulated environment.
" Previous experience working in a biopharmaceutical manufacturing
facility is preferred (CAR T a plus).
" An equivalent combination of education and experience may
substitute.
DUTIES AND RESPONSIBILITIES:
" Conduct thorough investigations (OOS, OOT, Environmental
Monitoring, deviations, etc.) utilizing root cause analysis
tools.
" Lead investigations and cross functional investigation teams, and
close reports in a timely manner
" Perform GEMBA walks with stakeholders to better understand
process steps and evaluate Root Cause Analysis.
" Work with functional teams to propose effective CAPAs, develop
CAPA plans and assure CAPA effectiveness.
" Assess potential impact and risk to product or process associated
changes may have upon change implementation and develop an
appropriate mitigation strategy.
" May Initiate change control documentation
" Identify functional area SMEs to perform impact assessments as
part of the change management process.
" Ensure all investigations are completed in a timely manner.
Notify stakeholders of any delays in a timely manner.
" Provide technical support for manufacturing investigations /
CAPAs / change controls as needed.
" Support deviation investigation defense during audits and site
inspections for QC compliance related inquiries.
" Handle complex issues and solve problems with minimal
guidance.
" Provide training to new investigations team members
" Serve as author or technical reviewer of departmental procedures
as appropriate.
" Support manufacturing and Quality Control testing of CAR T
products as needed.
" Employ lean manufacturing / six sigma principles to continuously
improve products, processes and systems.
" Continuously support S12, living the patients first mission and
fostering a Right First Time mindset.
Keywords: Axelon Services Corporation, New York , Scientist/Engineer, Engineering , Summit, New York
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