Packaging Development Engineer

Role Summary

Packaging Development Engineer based in Lexington, MA. Provide technical expertise for developing packaging and labeling material selection, qualification, and process implementation for new product programs. Author and review regulatory information packages and filings (IND/NDA/BLA). Execute or lead packaging projects from early-phase evaluation to the device sub-team, delivering manufacturable and regulatory-compliant concepts. Serve as the technical interface between marketing and R&D for packaging design and address technical challenges related to product stability and GMP manufacturing.

Responsibilities

• Provide technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs.
• Author and review regulatory information packages and filings (IND/NDA/BLA).
• Execute or lead all aspects of a packaging project delivering early phase evaluation to the device sub-team.
• Deliver on performance indicators including concept design solutions, visualization and prototyping, human factors studies, regulatory submissions support, and realistic, manufacturable design concepts.
• Execute technical transfer of packaging material and process specifications from development to commercial GMP manufacturing site.
• Ensure proper documentation and packaging-related compliance with regulations and cGMP.
• Interface between commercial marketing and R&D for packaging design.
• Evaluate and resolve technical challenges related to product stability and manufacturing under GMP expectations and requirements.

Qualifications

• Master’s degree in Packaging Science, Packaging Engineering, or related field, plus 3 years of related experience; OR Bachelor’s degree in Packaging Science, Packaging Engineering, or related field, plus 5 years of related experience.
• Prior experience must include design, develop and qualify sterile pharmaceutical, medical device and combination product packaging with demonstrated success and commercialization; demonstrate pharmaceutical packaging development knowledge for drug product manufacturing processes and/or packaging solutions for biologics in primary containers and devices; utilize cGMP requirements (ISO 13485, 21 CFR 820, 21 CFR 210, 21 CFR 211) and demonstrate application of industry guidance/standards documents (e.g., ISPE, PDA, ASTM, ISO, ICH, Pharmacopeias) for combination product submissions; develop and validate packaging testing methods and procedures following ISO 11607 for use in design verification testing; develop and validate packaging testing methods and procedures following compendia testing for CCIT (USP 1207, USP 381/382).

Skills

• Packaging design and development for sterile pharmaceutical, medical device, and combination products
• Regulatory submissions and information packages (IND/NDA/BLA)
• Technical transfer and process development
• Design verification testing and packaging testing methods following ISO 11607 and relevant USP compendia
• Knowledge of GMP/cGMP, ISO 13485, 21 CFR 820/210/211
• Experience with human factors studies
• Cross-functional collaboration (marketing, R&D, manufacturing)

Education

• Master’s degree in Packaging Science, Packaging Engineering, or related field; or Bachelor’s degree in Packaging Science, Packaging Engineering, or related field.

Additional Requirements

• Up to 25% domestic and international travel for vendor site visits, manufacturing site visits, and technical audits.
• Up to 40% remote work allowed.