Key Responsibilities:
Act as a technical advisor for global packaging projects and initiatives.
Design and qualify packaging system components to ensure compliance with international regulations.
Establish strong relationships with manufacturing site leadership to understand and anticipate packaging needs.
Deliver packaging solutions and strategies to support compliant packaging processes.
Collaborate with cross-functional teams (R&D, commercial, marketing, etc.) to develop new packaging technologies and platforms.
Manage package performance testing to meet regulatory and compendial compliance.
Drive and support packaging needs for primary container closure systems and custom package development projects.
Develop improved test methods, business processes, templates, SOPs, and standards.
Provide guidance for product transfers, material changes, and equivalency evaluations.
Maintain awareness of external regulatory environments to aid in strategy development.
Develop and deploy global packaging standards and drive execution of harmonized component and process standards.
Serve as a subject matter expert for packaging materials, testing, regulations, equipment, and processes.
Review and provide input on relevant site-level and global change controls.
Qualifications:
BSc Degree in Packaging Engineering, Engineering, Sciences, or a related field (MSc preferred).
10+ years of experience in pharmaceutical packaging, focusing on primary packaging componentry for non-sterile solid oral dose products.
Proficiency in creating and reviewing technical drawings, specifications, testing protocols, documents, and reports.
Fluent in English and Hungarian
Strong technical writing, problem-solving, and analytical skills.
Ability to manage multiple projects simultaneously and lead complex technical discussions.
Experience in compendia testing (USP, EP, JP), extractables/leachables, and impurities.
Participation in process improvement projects (e.g., Six Sigma).
Knowledge of packaging material science, technologies, equipment, and testing.
Understanding of global/regional pharmaceutical packaging regulations (FDA, EMEA).
Experience in packaging validation using ISO, ASTM, and ISTA standards.
