Senior Manufacturing Engineer
2 weeks ago
Position Overview:
As a Manufacturing Engineer II, 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 essential in supporting the manufacturing team across various production-related tasks.
Key Responsibilities:
- Deliver on-site support by engaging in daily GMP manufacturing operations.
- Implement manufacturing batch records, work instructions, and/or SOPs, emphasizing a 'right the first time' approach.
- Oversee, sanitize, prepare, and operate cell processing and expansion equipment in Grades A, B, and C cleanroom settings, adhering to established standard operating procedures and policies.
- Contribute as a team member in manufacturing operations, demonstrating a solid understanding of procedures, techniques, tools, materials, and equipment to facilitate cGMP activities.
- Collaborate with team members to prioritize workflows based on processes and available resources.
- Assist in all start-up and continuous improvement efforts 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 maintain compliance with internal protocols and regulatory standards.
- Work in partnership with cross-functional teams, stakeholders, and vendors to gather necessary background information for task completion.
- Provide manufacturing and operational insights in a professional and collaborative manner to all stakeholders.
- Uphold a high standard of accountability and integrity in all activities.
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 processes, including cell culture, cryopreservation, purification, filling, visual inspection, and aseptic processing.
- Ability to work autonomously and maintain focus 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 environments, and occasional lifting of heavy materials.
- Proven experience in drafting and reviewing technical documents with strong technical writing skills.
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