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Advanced Manufacturing Engineer II
2 months ago
Position Overview:
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 environment. This role involves supporting the manufacturing team across various production-related tasks.
Key Responsibilities:
- Provide on-site support by engaging in daily GMP manufacturing operations.
- Execute manufacturing batch records, work instructions, and SOPs, emphasizing a 'right the first time' approach.
- Oversee the monitoring, cleaning, preparation, and operation of cell processing and expansion equipment in Grades A, B, and C cleanroom settings, adhering to established standard operating procedures.
- Contribute as a team member in manufacturing operations, demonstrating a solid understanding of procedures, techniques, tools, materials, and equipment to support cGMP activities.
- Collaborate with cross-functional teams, partners, and vendors to gather essential information for task completion.
- Assist in all start-up and continuous improvement initiatives related to operational readiness and excellence, including the creation and revision of procedures, APS, and engineering runs.
- Draft and review SOPs, manage deviations, change controls, and CAPAs to ensure adherence to internal protocols and regulatory standards.
- 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 independently and remain focused in a dynamic environment without direct supervision.
- Knowledge of cGMP/FDA regulations, quality standards, documentation, and practices.
- Physical capability to perform tasks requiring dexterity and mobility, including routine walking, standing in cleanroom environments, and occasional lifting of heavy materials.
- Proficient in drafting and reviewing technical documents with strong technical writing skills.
