Jr. Manufacturing Engineer

Job Title: Jr. Manufacturing Engineer

Job Location: Gaithersburg, MD

Project Duration: 1 Year

Pay Rate: $45/hr- $55/hr (depending on experience)

Job Description:

This position will perform manufacturing oversight of an external contract manufacturing organization (CMO) producing a Phase II/III clinical CAR-T program as a Person-in-Plant (PIP). Additionally, this position will be responsible for supporting Client and the CMO in the following activities:

• On the Floor Technical Support and Issue Triage Support (i.e. rapid response to MFG issues, resolution, and communication / escalation)
• Facility Oversight, including routine GEMBA walks, reporting of observations to CMO / Client, and support in driving improvements where needed
• Support in technical writing/review for product impact assessment, investigations / deviations and change controls.
• Support in the execution and implementation of CAPAs.
• Support in technical writing/review for batch records, SOPs, and other documents as needed.
• Support in data transcription and analysis for manufacturing process and release data.

This position will be responsible for working with the contract manufacturing organization to drive improvements, oversee and support in manufacturing operations, ensure collaboration and communication, and oversee execution of tasks such as manufacturing investigations, change controls, batch record revisions, continuous improvement efforts and corrective and preventative actions (CAPA).

Experience Required/Needed:

• Minimum 3-5 years experience in pharmaceutical manufacturing, with preference in cell and gene therapy manufacturing.
• Preferred experience in working with the CliniMACS Prodigy Instrument

Preferred experience with contract manufacturing organizations