Description:
Subject Matter Expert on mixing, coating, drying, converting and packaging equipment. Participates in all equipment aspects of product development and manufacturing including execution of pilot clinical, exhibit, and validation batches, commercial batches. Responsible for training Operations staff on equipment procedures and batch execution and resolving manufacturing issues as they arise.
Essential Functions:
- Equipment set-up and maintenance for mixers, coaters, rotary converting equipment, packaging equipment, and cartoning equipment.
- Manufacture of pilot, exhibit, validation and commercial batches.
- Train operations team on equipment operation, procedures, and execution of batch records. Identify and implement process improvement , following GMP and Change Control requirements.
Additional Responsibilities:
- Facilitate transfer of materials for production activities.
- Assist formulation team in formulation development activities. Establish robust processing conditions for new product production.