Packaging Engineer

Proclinical; Zürich; Vor Ort; CHF 85.000 - 110.000; Vollzeit

Zusammenfassung

Proclinical is seeking a Packaging Engineer for a contract role based in Switzerland. You will manage packaging operations, documentation, and CMO collaborations across EU and ROW markets in a regulated environment.

Responsibilities include developing and qualifying packaging components, leading change control and CAPAs with QA, ensuring serialization and global labeling standards, and coordinating cross-functional teams across time zones.

Qualifikationen

• Bachelor's degree in an engineering field with packaging focus.
• Strong knowledge of cGMP documentation requirements.
• Experience with electronic documentation systems (Veeva or Trackwise).
• Experience developing and qualifying packaging components on equipment.
• Excellent communication, leadership, and project management skills.
• Fluent in English.

Aufgaben

• 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 development, qualification, and risk mitigation of alternate substrates, suppliers, and processes.
• Lead change control, non-conformances, and CAPA with Quality and Global Labeling Operations.
• Oversee platform harmonization and standardization of components.
• Manage bills of materials and ensure regulatory serialization and global labeling requirements.
• Facilitate inclusion of templates for regulatory and authentication requirements.
• Work on projects involving internal and external CMO operations across EU and Rest of World.

Kenntnisse

cGMP documentation

Leadership

Communication

Project management

Multitasking

English fluency

Cross-functional collaboration

Ausbildung

Bachelor's degree in Engineering (Packaging preferred)

Tools

Veeva

Trackwise

Jobbeschreibung

Ready to shape global pharmaceutical packaging operations while driving compliance, innovation, and quality across international manufacturing partners?

Proclinical is seeking a Packaging Engineer for a contract role based in Switzerland. This position focuses on managing packaging operations and documentation requirements, supporting external contract manufacturing organizations (CMOs), and ensuring compliance with global standards. The role involves working across time zones and collaborating with cross-functional teams to deliver high-quality results in a regulated environment.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

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.

Key Skills and Requirements:

• Bachelor's degree in an engineering-related field (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.