Position Overview: We are seeking a highly skilled Packaging Development Engineer to design, qualify, and implement secondary packaging solutions. The successful candidate will lead the development, approval, execution, and continuous improvement of packaging designs, ensuring compliance with both local and global requirements.

Key Responsibilities:

• Design and implement secondary packaging solutions, ensuring alignment with regulatory, quality, and customer requirements.
• Collaborate closely with packing operations, labeling development, Purchasing, and Supply teams to develop adequate packaging solutions.
  Work in partnership with packaging suppliers to select appropriate materials and establish technical specifications.
• Ensure timely and effective completion of projects according to established plans and budgets.
• Develop and maintain packaging technical specifications, ensuring compliance with any changes.
• Support the labeling change process by assessing the impact on packaging materials and packing operations.
• Ensure compliance with internal and external international standards for packaging design and validation.
• Draft protocols and reports to support all packaging design, material qualification, and validation activities as required.
• Apply sound engineering problem-solving techniques to packaging development and maintenance tasks, including design, analysis, material selection, inspection, and packing process requirements.
• Lead and conduct complex technical investigations related to packaging material nonconformities.
• Serve as a technical expert for all aspects of packaging design development and support implementation efforts.

Qualifications:

Bachelor or Master's degree with a minimum of 7 years of related experience in a regulated packaging operations environment.
Degree in Packaging Engineering or equivalent experience.
Experience in the biopharmaceutical industry or other highly regulated and compliance-focused industries.
Comprehensive understanding of all aspects of packaging development.
Familiarity with Change Management in a GMP environment.
Knowledge of packaging standards (ISTA 2A, ISTA 7D, ISO 11607, etc.).