We are looking for a Associate Engineer to join the raw materials team within the CTTO (Cell Therapy Technical Operations) department.
Requirements
- Support as a SME for raw materials including single-use systems (SUS) and material sciences.
- Provide technical support on in CAR-T commercial manufacturing.
- Lead projects involving the introduction and qualification of materials, second sourcing efforts, and development of material specifications.
- Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and supply chain robustness of existing raw materials.
- Deliver strategies for prioritizing and executing raw material projects, including the establishment and improvement of internal standards and business processes.
- Vendor management including change controls, audits, deviations, and QRM programs.
- Support investigations and ensure compliance with internal standards and requirements.
- Perform technical diligence visits to raw material supplier sites with cross-functional teams.
- Provide necessary technical analysis to support impact assessments and investigations.
- Support responses for Information Request (IR) from regulatory bodies.
Benefits
- Competitive hourly rate
- Working Hours: Monday - Friday, regular business hours
- 6-month contract with possible extension
- Health insurance
- Holiday pay
- 401(k) program
- Employee referral bonus program
