Senior Manufacturing Engineer

2 weeks ago

Columbia, South Carolina, United States CARsgen Therapeutics Full time

Position: Senior Manufacturing Engineer

As a Senior Manufacturing Engineer, you will play a crucial role in ensuring that production readiness and compliance initiatives are effectively implemented within the cGMP production framework. This role is integral to supporting the manufacturing team across various production-related tasks.

Key Responsibilities:

  • Provide hands-on support on the manufacturing floor, actively engaging in daily GMP production activities.
  • Execute manufacturing batch records, work instructions, and standard operating procedures (SOPs), emphasizing a 'right the first time' approach.
  • Oversee the monitoring, cleaning, preparation, and operation of cell processing and expansion equipment within Grades A, B, and C cleanroom environments, adhering to established procedures and policies.
  • Contribute as a valued team member in manufacturing operations, leveraging your understanding of procedures, techniques, tools, materials, and equipment to facilitate cGMP activities.
  • Engage in team-based decision-making, prioritizing workflows based on process requirements and available resources.
  • Support all start-up and continuous improvement initiatives related to operational readiness and excellence, including the creation and revision of procedures, engineering runs, and more.
  • Draft and review SOPs, manage deviations, change controls, and CAPAs to ensure adherence to internal protocols and regulatory standards.
  • Collaborate with cross-functional teams, partners, and vendors to gather essential information needed for task completion.
  • Provide professional and collaborative manufacturing and operational guidance to stakeholders.
  • Maintain a high level of accountability and integrity in all tasks.

Qualifications:

  • Bachelor's degree in a relevant scientific or engineering discipline.
  • A minimum of 4 years of experience in cGMP biologics manufacturing and/or commercial cell therapy operations.
  • Preferred experience in CAR-T manufacturing, including cell culture, cryopreservation, purification, filling, visual inspection, and aseptic processing.
  • Ability to work autonomously and remain focused in a dynamic environment without direct supervision.
  • Familiarity with cGMP/FDA regulations, quality standards, documentation, and practices.
  • Capability to perform physical tasks requiring dexterity and mobility, including routine walking, standing in cleanroom settings, and occasional lifting of heavy materials.
  • Proficient in drafting and reviewing technical documents with strong technical writing skills.

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