Senior Packaging Engineer

Bachelor’s degree in science, engineering, or another related technical field.
At least 5 years of related experience in packaging operations, biopharmaceutical, or highly regulated compliance industry.
Knowledge of packaging standard (ISTA 2A, ISTA 7D, ISO 11607).
Experience with packaging development.
General proficiency in negotiations with departments and vendors to resolve issues.

Develop and implement packaging concepts, characterizing secondary and tertiary components.
Select, test, and maintain packaging specifications; author and execute material qualification protocols.
Collaborate with sites to qualify packaging in equipment and processes, coordinating testing related to package qualification.
Develop, write, and approve documentation for GMP packaging and labeling activities.
Consult with purchasing, production, and quality departments to assess costs and feasibility of packaging solutions.
Provide technical support to quality, manufacturing/packaging operations, and supplier relationship management.
Assist with department support, including Change Requests, Non-conformance/CAPA, and improvement initiatives.
Act as Subject Matter Expert in packaging-related projects, ensuring compliance with regulatory standards.
Prepare packaging sections for regulatory submissions and participate in compliance inspections and audits.
Serve as technical expert for packaging development, ensuring compliance of artworks and technical profiles with criteria requirements.

No preferred qualifications provided.