Packaging Engineer / Packaging Technical Lead

more-jobs; Zürich; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

International (Schweiz) AG in Zürich seeks an experienced Packaging Engineer to manage global packaging activities across external CMOs, ensuring cGMP compliance and product quality. You will own documentation, specs, and BOMs while leading packaging component qualification and process validation.

The role requires a Bachelor's in Engineering and 5+ years in a regulated environment, with English fluency and TrackWise experience.

Qualifikationen

• Bachelor's degree in Engineering, Packaging Engineering, or related field.
• Minimum of 5 years' experience in a pharmaceutical or similarly regulated environment.
• Strong knowledge of cGMP and pharmaceutical documentation practices.
• Experience with packaging component qualification and packaging equipment.
• Fluency in English and mandatory TrackWise experience.

Aufgaben

• Manage packaging engineering activities across external CMOs, ensuring compliance, efficiency, and product quality.
• Own and maintain packaging-related documentation in compliance with cGMP requirements.
• Develop, review, and approve technical profile drawings, packaging specifications, purchasing specifications, and release documentation.
• Lead qualification and implementation of new packaging components and modifications to existing packaging systems.
• Support packaging process validation activities and technical troubleshooting.
• Manage Change Controls, Deviations, Investigations, and CAPA using electronic quality management systems.
• Coordinate implementation and standardization of packaging platform components across global operations.
• Maintain and manage Bills of Materials (BOMs) and packaging master data.
• Support qualification of alternative materials, suppliers, and processes to mitigate supply-chain risks.
• Ensure packaging and labeling compliance with global regulatory requirements, including serialization.

Kenntnisse

Packaging engineering

cGMP knowledge

Project management

English fluency

Technical communication

Ausbildung

Bachelor's degree in Engineering

Tools

TrackWise

Veeva

Jobbeschreibung

Packaging Engineer / Packaging Technical Lead (Pharma)

We are seeking an experienced Packaging Engineer to support and manage global packaging engineering activities across commercial pharmaceutical products. The role focuses on packaging operations within external Contract Manufacturing Organizations (CMOs), ensuring compliance with cGMP requirements, technical packaging standards, and global regulatory expectations.

Packaging Engineer / Packaging Technical Lead (Pharma)

Prestigious pharmaceutical company

Description

• Manage packaging engineering activities across external CMOs, ensuring compliance, efficiency, and product quality.
• Own and maintain packaging-related documentation in compliance with cGMP requirements.
• Develop, review, and approve technical profile drawings, packaging specifications, purchasing specifications, and release documentation.
• Lead the qualification and implementation of new packaging components and modifications to existing packaging systems.
• Support packaging process validation activities and technical troubleshooting.
• Manage Change Controls, Deviations, Investigations, and CAPA activities using electronic quality management systems.
• Coordinate the implementation and standardization of packaging platform components across global operations.
• Maintain and manage Bills of Materials (BOMs) and related packaging master data.
• Support the qualification of alternative materials, suppliers, and manufacturing processes to mitigate supply-chain risks.
• Ensure packaging and labeling compliance with global regulatory requirements, including serialization and product authentication initiatives.
• Support product launches, lifecycle management activities, and continuous improvement projects.
• Collaborate closely with Quality, Regulatory Affairs, Manufacturing, Supply Chain, and external CMO partners.
• Drive projects independently while understanding their broader strategic and business impact.

Profile

• Bachelor's Degree in Engineering, Packaging Engineering, or a related technical discipline.
• Minimum of 5 years of experience within the pharmaceutical industry or a similarly regulated environment.
• Strong knowledge of cGMP requirements and pharmaceutical documentation practices.
• Proven experience in packaging engineering, packaging process validation, and technical specification management.
• Hands-on experience with packaging component qualification and packaging equipment.
• Fluency in English.
• Mandatory experience with TrackWise.
• Experience managing technical drawings, packaging specifications, and design changes.
• Strong knowledge of electronic quality management systems.
• Experience with Veeva or similar document management systems is highly desirable.

Offer

Interested?
I look forward to your application.

• International (Schweiz) AG
  Sihlstrasse 37
  8001 Zürich