Job Title: Scientist/Engineer
Location: Summit, NJ
Type: Contract
Compensation: $42.94 - 54.54/hr
Contractor Work Model: Onsite
Hours: first shift (9am to 5pm) Monday to Friday
Overview
Leading pharmaceutical company looking for an experienced Scientist/Engineer. Ideal candidates should have aBachelor’s Degree in science or engineering and at least 3 years relevant work experience in a regulated environment, preferably in biopharmaceutical manufacturing.
Responsibilities
- Lead manufacturing and QC investigation reports in support of S12 CAR T operations, including root cause investigations, interviewing personnel, hypothesis testing, and interpreting results.
- Author investigation reports, identify CAPAs, and troubleshoot complex problems while interfacing with cross-functional teams, including Quality Assurance.
- Conduct deviation investigations utilizing root cause analysis tools and lead cross-functional investigation teams to closure in a timely manner.
- Perform GEMBA walks with stakeholders to understand processes and evaluate root causes.
- Develop and support effective CAPAs, assess potential impacts, and manage change controls as needed.
- Provide technical support for investigations, audits, and inspections, ensuring compliance with cGMP and global regulatory requirements.
- Train new team members on investigation processes and serve as technical reviewer for departmental procedures.
- Support manufacturing and QC testing of CAR T products, employing lean manufacturing and Six Sigma principles for continuous improvement.
- Support a patient-first mission by fostering a Right First Time mindset and ensuring all investigations are completed efficiently.
Requirements- Working experience of deviation investigations utilizing root cause analysis tools.
- Experience in the CAPA process, including effectiveness verification.
- Technical writing skills and ability to collaborate effectively with cross-functional teams.
- Bachelor’s Degree in science or engineering; advanced degree preferred.
- Minimum 3 years relevant work experience in a regulated environment, preferably in biopharmaceutical manufacturing.
- Previous experience with CAR T or biopharmaceutical manufacturing and Quality Control preferred.
- Ability to conduct impact assessments, handle complex issues, and provide technical training.
- Familiarity with electronic Quality systems such as eQRMs.
- Knowledge of data trending, statistical analysis software, and regulatory compliance.
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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Ref: #558-Scientific
