Scientist/Engineer

On-Board Scientific is hiring a Scientist / Engineer in Summit, NJ!

For immediate consideration please send your resume to [email protected]

Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match.

Subject Line : Position, Title, and State you are Located

About Us :

On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees.

We offer benefits as well as 401k.

Position Details :

Title : Scientist / Engineer

Position Type : Full Time / 6-month contract, possibility of extension depending on needs of company and performance of candidate.

Job location : Summit, NJ

Shift : M-F, business hours

Compensation : $60.50 hourly (Based on Experience)

Summary :

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.

Responsibilities / Duties :

• 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.

Qualifications :

• 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.
• 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.

Apply Today!

www.onboardusa.com

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.

On-Board’s Mission is to provide Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability, or genetics.

JD# 23-02662

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