top of page

Scientist / Engineer

Job Location
Job Type
Workspace

Summit, NJ

Engineer

On-site position (no remote or hybrid options)

Target Hiring Date

Urgent, Feb 2025

Work Authorization

Applicants must have the legal right to work in the United States without requiring sponsorship.  

Corp-to-Corp (C2C) arrangements are not accepted.

Requirements

Education:

  • Bachelor's degree in science or engineering, preferably in biochemistry, life sciences, or a related engineering discipline (advanced degree preferred).


Qualifications:

  • 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 Conditions:

  • This role may involve working in an office, laboratory, or manufacturing area. 

  • Must be able to work in gowning attire within a controlled environment for extended periods. 

  • Must demonstrate the ability to work safely with hazardous, radioactive, and biological materials and waste, ensuring safety both when working independently and with others. 

  • Must be able to lift up to 15 pounds as needed. 

About the 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.

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.

About the Company

Join Sokol GxP Services – Where Innovation Meets Integrity!

Join Sokol GxP Services, where we partner with leading pharmaceutical and biotech companies to provide exceptional Commissioning, Qualification, and Validation (CQV) services. We are committed to fostering diversity, empowering local talent, and building strong community connections to bring the best-qualified candidates to our clients in the Summit, NJ area. Our inclusive and collaborative culture promotes growth and innovation, offering competitive health benefits, PTO, holiday pay, volunteer hours, a relocation budget*, a 401K** program, and professional development opportunities. Plus, take advantage of our Employee Referral program! Be part of a dynamic team with fantastic opportunities for growth and professional development!

Let’s shape the future of life sciences together!

All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the from the date of receipt.

Equal Opportunity Employer Statement:
Sokol GxP Services is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

*Relocation support will be determined on a case-by-case basis.
**Our 401K program is set to launch in the 2025 fiscal year.

By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.

bottom of page