Packaging Development Engineer
Katalyst HealthCares & Life Sciences
Packaging Development Engineer
We are seeking a Packaging Development Engineer to design, develop, validate, and optimize packaging systems for new and existing products. This role collaborates closely with R&D, Manufacturing, Quality, Regulatory, and Supply Chain teams to ensure packaging solutions meet performance, regulatory, cost, and sustainability requirements. The ideal candidate has experience in package design, testing, validation, and commercialization within a regulated manufacturing environment. Responsibilities include:
- Design and develop primary, secondary, and tertiary packaging solutions for new and existing products.
- Lead packaging development projects from concept through commercialization.
- Evaluate packaging materials and components for functionality, quality, and cost-effectiveness.
- Develop packaging specifications, drawings, and technical documentation.
- Plan and execute package validation activities, including transit, distribution, and shelf-life testing.
- Collaborate with suppliers to qualify new packaging materials and resolve technical issues.
- Support manufacturing line trials, packaging equipment validation, and process improvements.
- Conduct root cause investigations and implement corrective actions for packaging-related issues.
- Ensure compliance with GMP, FDA, ISO, ASTM, ISTA, and other applicable standards.
- Partner with cross-functional teams including Engineering, Quality, Regulatory Affairs, Operations, and Procurement.
- Support cost reduction, sustainability, and continuous improvement initiatives.
- Maintain Design History Files (DHF), change controls, risk assessments, and technical reports.
Requirements:
- Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, Materials Science, or a related engineering discipline.
- 2–5 years of experience in packaging development, package engineering, or product development.
- Experience with packaging materials such as plastics, paperboard, corrugated packaging, labels, films, foams, or glass.
- Knowledge of packaging validation and performance testing.
- Experience working with CAD software for packaging design is preferred.
- Strong problem-solving, analytical, and project management skills.
- Excellent written and verbal communication skills.
Preferred Qualifications:
- Experience in pharmaceutical, medical device, biotechnology, consumer products, food & beverage, or manufacturing industries.
- Knowledge of ISTA, ASTM, ISO 11607, FDA, and GMP requirements.
- Experience with packaging line equipment and automation.
- Familiarity with Lean Manufacturing, Six Sigma, or Design for Manufacturability (DFM).
- Experience with supplier qualification and package commercialization.
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