EU Packaging Engineer — cGMP, CMO & QA Expert

Swisslinx AG; Zürich; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Swisslinx AG is seeking an EU-based Packaging Engineer to act as a subject matter expert supporting packaging activities across external CMOs and internal operations. You will oversee packaging engineering activities and documentation for commercial pharmaceutical products, ensuring cGMP compliance and lifecycle support.

You will lead change controls, track quality documentation in TrackWise, and collaborate with global teams to manage packaging components, specifications and serialization

Qualifikationen

• Bachelor’s degree in Engineering or a related technical field is required.
• Minimum 5 years of pharmaceutical packaging experience or equivalent.
• Strong hands-on experience in pharmaceutical packaging engineering.
• Knowledge of cGMP documentation requirements.
• Experience developing and qualifying packaging components on packaging equipment.
• Experience with packaging process validation and qualification.
• Experience managing change controls, deviations/investigations, non-conformances and CAPAs.
• TrackWise experience is mandatory.

Aufgaben

• Manage packaging engineering activities and documentation across external CMO operations.
• Develop, review, approve and implement technical profile drawings and packaging component specifications.
• Support the development and qualification of packaging components on packaging equipment.
• Lead packaging process validation and qualification activities.
• Manage change controls, non-conformances, deviations/investigations and CAPA activities with Quality and cross-functional teams.
• Maintain quality documentation within TrackWise and ensure audit readiness.
• Collaborate with CMOs and internal stakeholders across functions, countries and time zones.

Kenntnisse

Packaging engineering

cGMP documentation

Project management

Stakeholder management

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Engineering or related field

Tools

TrackWise

Jobbeschreibung

Swisslinx AG is seeking an EU-based Packaging Engineer to act as a subject matter expert supporting packaging activities across external CMOs and internal operations. You will oversee packaging engineering activities and documentation for commercial pharmaceutical products, ensuring cGMP compliance and lifecycle support.

You will lead change controls, track quality documentation in TrackWise, and collaborate with global teams to manage packaging components, specifications and serialization