Engineering - Assistant/Associate Scientist - TechDigital
Summit, NJ
About the Job
100% onsite
Position Title:
Associate Scientist/Engineer, Investigations Team
PURPOSE AND SCOPE OF POSITION:
The Associate Scientist/Engineer is responsible for leading 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) or Infinity.
• Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality
Control.
•
Education and Experience:
• Requires a Bachelor's Degree in science or engineering
in Biochemistry, life sciences or related engineering discipline (advanced
degree preferred).
• Minimum 1 year 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).
DUTIES AND RESPONSIBILITIES:
• Conduct thorough investigations (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 related inquiries.
•Serve as author or technical reviewer of departmental procedures as appropriate.
• 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.
WORKING CONDITIONS (US Only):
• The incumbent will be working 80% to 90% of the time in an office environment.
• The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory
setting.
• The incumbent may travel between NJ sites for training, meetings or corporate events on
occasion.
• The incumbent will need to have flexibility to work extended hours (>8 hours/day),
weekend and/or holidays when required to meet deadlines.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management based on business needs.
Position Title:
Associate Scientist/Engineer, Investigations Team
PURPOSE AND SCOPE OF POSITION:
The Associate Scientist/Engineer is responsible for leading 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) or Infinity.
• Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality
Control.
•
Education and Experience:
• Requires a Bachelor's Degree in science or engineering
in Biochemistry, life sciences or related engineering discipline (advanced
degree preferred).
• Minimum 1 year 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).
DUTIES AND RESPONSIBILITIES:
• Conduct thorough investigations (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 related inquiries.
•Serve as author or technical reviewer of departmental procedures as appropriate.
• 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.
WORKING CONDITIONS (US Only):
• The incumbent will be working 80% to 90% of the time in an office environment.
• The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory
setting.
• The incumbent may travel between NJ sites for training, meetings or corporate events on
occasion.
• The incumbent will need to have flexibility to work extended hours (>8 hours/day),
weekend and/or holidays when required to meet deadlines.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management based on business needs.
Source : TechDigital