Packaging Engineer

Shape Global Pharmaceutical Packaging Operations

Drive compliance, innovation, and quality across international manufacturing partners by managing packaging operations and documentation requirements. This role supports external contract manufacturing organizations (CMOs) and ensures adherence to global standards within a regulated environment. The position requires working across time zones and collaborating with cross-functional teams to deliver high-quality results.

Key Responsibilities

• Manage CMO activities, including documentation requirements for packaging operations.
• Develop, review, and approve technical profile drawings and purchasing-release specifications.
• Qualify packaging components on packaging equipment and manage packaging process validation.
• Support the development, qualification, and risk mitigation of alternate component substrates, suppliers, and processes.
• Lead or own change control, non-conformances, and CAPA activities in collaboration with Quality and Global Labeling Operations.
• Oversee the implementation of platform harmonization and standardization of components.
• Manage bills of materials and ensure regulatory serialization and global corporate standard labeling requirements are met.
• Facilitate the inclusion of templates for regulatory and authentication requirements.
• Work on projects involving both internal and external CMO operations, focusing on EU and Rest of World markets.

Essential Skills and Requirements

• Bachelor's degree in an engineering-related field, with Packaging Engineering preferred.
• Strong knowledge of cGMP documentation requirements.
• Proficiency in electronic documentation systems such as Veeva or Trackwise.
• Experience in developing and qualifying packaging components on packaging equipment.
• Strong technical, interpersonal, communication, and leadership skills.
• Ability to manage multiple tasks in a dynamic environment with minimal supervision.
• Demonstrated organizational skills, including project management.
• Fluency in English.
• Right to work in Switzerland or hold an EU passport.