Drug Formulation Manufacturing Engineer, Drug Product

Summary:

• Critical role in supporting the startup of a state-of-the-art aseptic manufacturing facility with multiple production lines. Reporting to the Formulation Supervisor of Commercial Drug Product, this position will serve as an end-user for Thawing and Formulation area, including its equipment, facility, supporting systems, and utilities, in preparation for aseptic manufacturing operations.

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 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.

Qualification:

• Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
• Direct experience in drug product manufacturing such as thawing and formulation, or closely related area, is preferred.
• 2+ years in drug product manufacturing.