Packaging Engineer II

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** Key Responsibilities
*** Lead packaging development activities for clinical programs, ensuring alignment with product requirements, regulatory expectations, and global standards.
* Apply sound engineering principles and industry standards (e.g., USP, ISO, ASTM) to the design and qualification of container closure systems (CCS).
* Author and execute packaging studies, including protocols and reports for component qualification, shipping validation, and compatibility assessments.
* Conduct and support equipment and process qualification activities (IQ/OQ/PQ) for packaging lines and configurations at internal and external manufacturing sites.
* Ensure packaging components and systems comply with current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines.
* Investigate and resolve packaging-related deviations, non-conformances, and complaints in collaboration with Quality and Operations teams.
* Support regulatory submissions by authoring and reviewing relevant sections of INDs, NDAs, BLAs, and other global filings.
* Maintain and author SOPs related to packaging development and ensure alignment with broader organizational procedures.
* Train new team members on packaging-related SOPs, documentation systems, and best practices.
* Collaborate with external partners including CMOs, suppliers, and test laboratories to ensure timely and compliant execution of packaging activities.
* Travel up to 20% may be required to support project execution at external sites.## ##
** Basic Qualifications
*** Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related scientific discipline.
* At least 4 years of relevant experience in pharmaceutical, biotechnology, or medical device packaging development. Advanced degrees with commensurate experience will be considered.
* Demonstrated experience in packaging component characterization, qualification, and regulatory documentation.
* Strong working knowledge of cGMP, FDA, EMA, and ICH guidelines as they pertain to packaging systems.
* Proficiency in applying industry standards such as ASTM D4169, ISO 11607, and others relevant to packaging and CCS.
* Excellent written and verbal communication skills, with the ability to clearly document technical work and communicate across functions.
* Strong organizational and project management skills, with the ability to manage multiple priorities in a fast-paced environment.
* Experience working with external suppliers, CMOs, and contract laboratories is highly desirable.
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