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Process Engineer

Job Attributes

Job Id:

18643

Job Category:

Clinical & Life Sciences

Job Location:

Warren, NJ  07059

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Companies is currently looking for a CAR-T Process Engineer and Technology Support Consultant in Summit, NJ to join a global pharmaceutical company dedicated to the development and commercialization of innovative cancer cell therapies.

 

The Process Engineer is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Collaborates with SME from the Development Group, Manufacturing Group, and Quality Group while providing technical support for the resolution of process deviations, the evaluation and implementation of process changes and continuous improvement support to the production operations.
 

 

Responsibilities of the Process Engineer include:

  • Maintain permanent inspection readiness and actively support regulatory inspections

  • Interface with operators and serve as process SME. Learn the procedures, analytics and document any known sensitivity.

  • Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during production

  • Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements

  • Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)

  • Lead project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management

  • Interface with regulatory authorities as required to support Manufacturing Operations audits

  • Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs

 

Qualifications for the Process Engineer:

  • 5+ years of Manufacturing support in GMP environment, facility/clean room design

  • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities

  • Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies

  • Must be able to prioritize and provide clear direction

  • CAR-T experience is key or similar- cell culture, biologics

  • Bachelor's Degree in Science or Engineering related field

 

Compensation for the Process Engineer position includes:

  • Commensurate to experience

  • Full Benefits, Vacation, PTO

 

Please send resumes to Karen Pallone at kkpallone@pipercompanies.com

Apply Now

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New Search

Job Id:

18643

Job Category:

Clinical & Life Sciences

Job Location:

Warren, NJ  07059

Security Clearance:

No Clearance

Business Unit:

Piper Companies