Engineering - Associate Scientist
Spectraforce
Summit, New Jersey
13 hours ago
Job Description
Position: Engineering - Associate Scientist
Duration: 6 Months
Location: Summit, NJ
100% onsite
Work Schedule: Mon-Fri(normal business hours)
PURPOSE AND SCOPE OF POSITION:
The Associate Scientist/Engineer is responsible for leading investigation reports in support of S12 CART operations. This includes execution of thorough root cause investigations, interviewing personnel,hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective andpreventive 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:
• Minimum Associate degree required or preferred a Bachelor’s Degree in science or engineering, preferablyin Biochemistry, life sciences or related engineering discipline.
• Minimum 1 year of relevant work experience, preferably in a healthauthority regulated environment.
• Previous experience working in a biopharmaceutical manufacturingfacility is preferred (CAR T a plus).
• An equivalent combination of education and experience maysubstitute.
DUTIES AND RESPONSIBILITIES:
• Conduct thorough investigations (Environmental Monitoring, deviations, etc.) utilizing rootcause analysis tools.
• Lead investigations and cross functional investigation teams, and close reports in a timelymanner
• Perform GEMBA walks with stakeholders to better understand process steps and evaluateRoot Cause Analysis.
• Work with functional teams to propose effective CAPAs, develop CAPA plans and assureCAPA effectiveness.
• Assess potential impact and risk to product or process associated changes may have uponchange implementation and develop an appropriate mitigation strategy.
• May Initiate change control documentation
• Identify functional area SMEs to perform impact assessments as part of the changemanagement process.
• Ensure all investigations are completed in a timely manner. Notify stakeholders of anydelays in a timely manner.
• Provide technical support for manufacturing investigations / CAPAs / change controls asneeded.
• Support deviation investigation defense during audits and site inspections related inquiries.
• Handle complex issues and solve problems with minimal guidance.
• Serve as author or technical reviewer of departmental procedures as appropriate.
• Employ lean manufacturing / six sigma principles to continuously improve products, processes andsystems.
• 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 laboratorysetting.
• The incumbent may travel between NJ sites for training, meetings or corporate events onoccasion.
• The incumbent will need to have flexibility to work extended hours (>8 hours/day),weekend and/or holidays when required to meet deadlines.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 47.00/daily.
Duration: 6 Months
Location: Summit, NJ
100% onsite
Work Schedule: Mon-Fri(normal business hours)
PURPOSE AND SCOPE OF POSITION:
The Associate Scientist/Engineer is responsible for leading investigation reports in support of S12 CART operations. This includes execution of thorough root cause investigations, interviewing personnel,hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective andpreventive 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:
• Minimum Associate degree required or preferred a Bachelor’s Degree in science or engineering, preferablyin Biochemistry, life sciences or related engineering discipline.
• Minimum 1 year of relevant work experience, preferably in a healthauthority regulated environment.
• Previous experience working in a biopharmaceutical manufacturingfacility is preferred (CAR T a plus).
• An equivalent combination of education and experience maysubstitute.
DUTIES AND RESPONSIBILITIES:
• Conduct thorough investigations (Environmental Monitoring, deviations, etc.) utilizing rootcause analysis tools.
• Lead investigations and cross functional investigation teams, and close reports in a timelymanner
• Perform GEMBA walks with stakeholders to better understand process steps and evaluateRoot Cause Analysis.
• Work with functional teams to propose effective CAPAs, develop CAPA plans and assureCAPA effectiveness.
• Assess potential impact and risk to product or process associated changes may have uponchange implementation and develop an appropriate mitigation strategy.
• May Initiate change control documentation
• Identify functional area SMEs to perform impact assessments as part of the changemanagement process.
• Ensure all investigations are completed in a timely manner. Notify stakeholders of anydelays in a timely manner.
• Provide technical support for manufacturing investigations / CAPAs / change controls asneeded.
• Support deviation investigation defense during audits and site inspections related inquiries.
• Handle complex issues and solve problems with minimal guidance.
• Serve as author or technical reviewer of departmental procedures as appropriate.
• Employ lean manufacturing / six sigma principles to continuously improve products, processes andsystems.
• 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 laboratorysetting.
• The incumbent may travel between NJ sites for training, meetings or corporate events onoccasion.
• The incumbent will need to have flexibility to work extended hours (>8 hours/day),weekend and/or holidays when required to meet deadlines.
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 47.00/daily.