What are the responsibilities and job description for the Engineering Scientist position at SOKOL GxP Services?
Job Title :
Engineering - Scientist / Engineer
Department :
Global Product Development and Supply
Location : Summit, NJ
Job Type : On-site
Reporting Structure :
Client, SOKOL
Effective Date : 01 / 27 / 2025
Pay range : 48 per hour
FLSA Classification :
FT | Non-Exempt
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.
ABOUT US :
SOKOL GxP Services is a rapidly expanding provider of Commissioning, Qualification, and Validation (CQV), Computer System Validation (CSV), and a full suite of GxP services tailored to the pharmaceutical, biotechnology, cell therapy, and medical device industries. Our mission is to help clients achieve regulatory compliance while upholding the highest standards of product quality and safety.
Our customized solutions are designed to guide clients through complex regulatory landscapes, enhancing the efficiency and compliance of their GxP processes. At SOKOL, we’re committed to empowering our clients with the expertise and precision needed to confidently meet and exceed industry standards.
Crafting GxP Excellence!
JOB DESCRIPTION :
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 promptly
- 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 promptly. Notify stakeholders of any delays promptly.
- 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.
EDUCATION :
QUALIFICATIONS :
WORKING CONDITIONS :
What We Offer :
Join SOKOL GxP Services! We partner with top pharmaceutical and biotech companies to deliver exceptional GxP and compliance services. At SOKOL, we’re dedicated to fostering diversity, supporting local talent, and building strong community connections to connect the best-qualified candidates with our clients. Be part of a dynamic team where you can shape the future of life sciences and advance your career in a collaborative, innovative environment. Our culture promotes growth and inclusivity, with a commitment to professional development and competitive benefits, including :
Salary : $48
