Role & Responsibilities
Support the installation and qualification of new manufacturing equipment, and own/oversee key equipment packages. Support the development and implementation of operational procedures, including SOPs, master batch records, and work instructions. Ensure adherence to quality standards and client requirements for aseptic processes such as thawing and formulation and other processing steps as required during the initial site startup. Collaborate with Engineering, Maintenance, and Validation to ensure timely calibration and validation of production equipment. Stay informed on global regulatory requirements (FDA, EMA, PIC/S, ICH) for aseptic manufacturing and product introduction, and remain up to date on current Good Manufacturing Practices (cGMP). Maintain thawing and formulation rooms and ensure adherence to stringent requirements, with flexibility for the execution during off-hours. Travel as necessary and be available for extended period of overseas training. ...