Global Packaging Engineer - Regulatory Compliance & CMO Ops

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

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.