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Regulatory Compliance Expert
1 week ago
We are looking for a talented Assistant Process Sciences Engineer to join our dynamic team at FUJIFILM Diosynth Biotechnologies. As an Assistant Process Sciences Engineer, you will be responsible for providing scientific, technical, and industry expertise to address issues in the technology transfer and implementation of client specified manufacturing processes for biologics. You will work closely with cross-functional teams to ensure seamless transfer of processes and implement effective solutions.
Main Responsibilities
- Apply knowledge of single-use manufacturing equipment and materials to support process implementation.
- Prepare user requirements, vendor quotes, and purchasing of equipment to support process implementation.
- Provide technical information for the preparation of change controls, protocols, and new user training for process equipment.
- Identify and procure raw materials and consumables of appropriate quality for cGMP execution of client specified manufacturing processes.
Requirements
- Bachelor's Degree in a relevant field (Chemistry, Biology, Life Sciences or related field).
- Hands-on laboratory or manufacturing experience with biologics projects.
- Knowledge of regulatory compliance and cGMP guidelines.
