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Process Engineering Specialist

2 months ago

Durham, North Carolina, United States CARsgen Therapeutics Full time

Join Our Innovative Team at CARsgen Therapeutics

We are excited to announce an opening for a Process Engineering Specialist at CARsgen Therapeutics. This position presents a remarkable opportunity to enhance your professional journey in Engineering and Maintenance while playing a vital role in the development of advanced CAR-T therapy manufacturing. In this role, you will be tasked with overseeing and organizing maintenance efforts for process, facility, and analytical apparatus within our GMP manufacturing environment. Collaboration with both internal teams and external partners will be essential to ensure optimal operations and support for production systems.

Key Responsibilities:

  • Oversee maintenance operations within a GMP-compliant process facility
  • Review and refine controlled documentation
  • Create and uphold Standard Operating Procedures (SOPs) and equipment documentation
  • Administer Computerized Maintenance Management System (CMMS) assets and work orders
  • Oversee the Environmental Monitoring System
  • Revise facility schematics
  • Assist in investigations and follow-up actions for quality assurance

Qualifications:

  • Bachelor's degree in engineering or life sciences
  • A minimum of 3 years of experience in a GMP manufacturing setting
  • Understanding of maintenance protocols in a GMP environment
  • Excellent communication and organizational abilities
  • Familiarity with CMMS and maintenance record-keeping
  • Prior experience with GMP process and analytical instruments
  • Experience managing quality assurance processes
  • Capability to operate within a regulated manufacturing framework