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Senior Manufacturing Engineer
2 months ago
Position Overview:
As a Manufacturing Engineer II, you will play a crucial role in ensuring that initiatives related to production readiness and compliance are effectively implemented within the scope of cGMP production. This role is integral to supporting the manufacturing team across various production-related functions.
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, clean, prepare, and operate cell processing and cell 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, leveraging a solid understanding of procedures, techniques, tools, materials, and equipment to support cGMP activities at the facility.
- Collaborate with team members to prioritize workflows based on processes and available resources.
- Assist in all start-up and continuous improvement initiatives related to operational readiness and excellence, including procedure development and revisions, APS, and engineering runs.
- Draft and review SOPs, manage deviations, change controls, and CAPAs to maintain compliance with internal protocols and regulatory standards.
- Work collaboratively with cross-functional teams, partners, and vendors to gather necessary background information for completing assignments.
- Provide operational and manufacturing guidance to stakeholders in a professional and collaborative manner.
- Uphold a high level 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.