Process Engineering Specialist

2 weeks 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 career in Engineering while playing a vital role in the manufacturing of advanced CAR-T therapies. As a Process Engineering Specialist, you will oversee and manage maintenance operations for process, facility, and analytical equipment within our GMP manufacturing environment. Collaboration with both internal teams and external partners will be essential to ensure efficient operations and support production workflows.

Key Responsibilities:

  • Oversee maintenance operations in 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 address quality control action items

Qualifications:

  • Bachelor's degree in engineering or life sciences
  • At least 3 years of experience in a GMP manufacturing setting
  • Familiarity with maintenance practices in a GMP environment
  • Excellent communication and organizational abilities
  • Experience with CMMS and maintenance record-keeping
  • Prior exposure to GMP process and analytical equipment
  • Knowledge of quality control procedures
  • Capability to operate in a regulated manufacturing context


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