Packaging Engineer

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

As a Packaging Engineer, you will act as an EU-based subject matter expert supporting packaging activities across external Contract Manufacturing Organizations (CMOs), with potential involvement in internal packaging operations.

You will manage packaging engineering activities and associated documentation across commercial pharmaceutical products, ensuring compliance with cGMP requirements and supporting changes throughout the product lifecycle.

Requirements

• Manage packaging engineering activities and documentation requirements 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 in collaboration with Quality and other cross-functional teams.
• Manage quality documentation within TrackWise and ensure documentation is complete, compliant and audit-ready.
• Support the qualification of alternative component materials, suppliers and processes to mitigate supply risks.
• Manage packaging component changes across US, EU and Rest of World markets.
• Support the implementation and standardisation of packaging components across platforms.
• Maintain and manage Bills of Materials and associated packaging documentation.
• Support regulatory and corporate labelling requirements, including serialization and authentication requirements.
• Collaborate closely with Packaging, Quality, Global Labeling Operations and other internal stakeholders, as well as technical experts at external CMOs.
• Manage multiple projects and priorities independently while ensuring delivery on time, in full and right first time.

Competences

• Bachelor’s degree in Engineering or a related technical field; Packaging Engineering is preferred.
• Minimum 5 years of pharmaceutical industry experience or equivalent relevant experience.
• Strong hands-on experience within pharmaceutical packaging engineering.
• Strong knowledge of cGMP documentation requirements.
• Proven experience developing and qualifying packaging components on packaging equipment.
• Experience with packaging process validation and qualification.
• Strong experience developing, reviewing and approving technical specifications, profile drawings and packaging component specifications.
• Hands-on experience managing change controls, deviations/investigations, non-conformances and CAPAs.
• TrackWise experience is mandatory.
• Experience working with CMOs and external manufacturing environments is highly desirable.
• Strong project management and organisational skills with the ability to manage multiple priorities independently.
• Comfortable working across functions, countries and time zones within a global matrix organisation.
• Strong communication, stakeholder management and influencing skills.

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