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Unither Pharmaceuticals

Packaging Engineering Technician I

ROCHESTER, NYPosted 3 weeks ago

Job Description

JOB SUMMARY: The Packaging Engineering Technician I will manage and conduct line trials, evaluate packaging processes to identify and implement improvements in quality and efficiency. This position provides technical support to Purchasing, Quality, Operations, Product Development, and Regulatory Affairs on matters related to materials, secondary and tertiary packaging components, artwork and labeling. This role supports the development and maintenance of packaging component specifications, packaging equipment settings, and related records and change management of packaging and labeling components, including shippers and associated documentation. Success in this role requires active involvement in the assessment of new or modified materials, investigation and resolution of non-compliant components, support of new product development initiatives, and the preparation and maintenance of regulatory documentation. B. ESSENTIAL DUTIES / RESPONSIBILITIES: Packaging Components that Meet Customer Requirements (60%) •Manage and implement changes to packaging materials and components, including labels, cartons, foils, and other printed or structural elements. •Coordinate and execute packaging trials for new formats and material validations to ensure manufacturability and operational readiness. •Collaborate cross-functionally with Supply Chain, Quality, Production, Engineering, and Operations to ensure successful execution of packaging changes and line trials. •Establish and maintain specifications and source files for secondary and tertiary packaging, including both structural and printed components. •Evaluate and implement change controls, including supplier material/process changes, component deviations, and manufacturing improvements. •Design and optimize pallet configurations using software (e.g., TOPS) to support packaging operations, distribution requirements, and ERP system setup. •Support new product launches by providing packaging expertise, including specification development, artwork coordination, labeling, and pallet pattern creation. •Partner with Regulatory Affairs, Quality Assurance, and Business Development to ensure compliance and alignment with project goals. •Maintain current knowledge of cGMP standards, FDA regulations, and industry best practices related to pharmaceutical packaging, labeling, and printing processes. •Drive continuous improvement initiatives in packaging components to enhance production efficiency, reduce costs, improve supply reliability, and optimize product protection and user convenience. Effective Efficient Processes (40%) •Ensure the development, documentation, and implementation of standardized processes for key business functions. •Identify document changes that would enhance the processes and ensure that all change control documentation is implemented. •Identify and implement ways to streamline and improve efficiency while maintaining process effectiveness. Challenges the way it has always been done. •Understand the regulatory environment and industry trends to identify ways to improve process quality and compliance. •Identify the impact of available technology on business processes and ensure that it is used to maximum advantage. •Ensure stakeholders are appropriately trained in the process and any process changes.

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1001-5000 employees
Paris, Ile de France, FR
Website