Formulation Engineer, Drug Product Operations

5 days ago


Singapore WuXi Biologics Full time

Formulation Engineer, Drug Product Operations Support the installation and qualification of new manufacturing equipment, and own/oversee key equipment packages. Develop and implement 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 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 current on Good Manufacturing Practices (cGMP). Maintain thawing and formulation rooms and ensure strict adherence to requirements, including flexible execution during off‐hours. Travel as necessary and be available for extended overseas training. Education Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences, or a related field. Experience 2+ years in drug product manufacturing. Skills Direct experience in drug product manufacturing such as thawing and formulation, or a closely related area. Strong interpersonal skills and ability to interact effectively with managers and peers. Seniority Level Mid‐Senior level Employment Type Full‐time Job Function Manufacturing Industry Pharmaceutical Manufacturing #J-18808-Ljbffr



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