Job Description

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Position Title:	Packaging Engineer
Department:	Operations
Reports To:	Engineering Manager
FLSA:	Exempt
Grade:	C2
Date:	2008/10/17

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Purpose and Scope

Develop new package requirements and maintain quality of existing packages for all product groups and define package requirements for product groups and customer requirements.

Essential Duties & Responsibilities

• Work with project team to select and test primary packaging components for developmental products.
• Work with vendors on the development of new packaging components/labeling.
• Write specifications for packaging components.
• Coordinate shipping, U.S.P, and sterility assurance testing.
• Routine management of packaging component, packaging equipment, and labeling vendors.
• Evaluate/design packaging operations to optimize productivity and quality.
• Author/edit Standard Operating Procedures for packaging processes.
• Assist in the research/selection of new packaging equipment.
• Act as a Manufacturing representative in the acquisition of new packaging equipment/systems.
• Author/edit manufacturing batch records (as they relate to packaging processes).
• Train personnel on packaging equipment.
• Conduct factory acceptance testing on new packaging equipment.
• Create and execute validation protocols on all appropriate packaging equipment and facilities.
• Drive improvement on existing products/processes.
• Provide technical assessment for packaging of products currently in development and in Phase I, II and III clinical trials.
• Assist in writing and reviewing container closure sections of IND's, NDA's, ANDA's and associated supplements.
• Special projects and other duties as assigned.

Knowledge, Skills & Abilities

• Knowledge of primary packaging materials, specifically those used in the pharmaceutical or health care industry.
• Strong knowledge of packaging equipment and film converting equipment.
• Demonstrated skill in successfully coordinating projects among departments.
• Skill in effective oral and written communication.
• Ability to handle multiple complex projects simultaneously.
• Ability to be self-motivated and work effectively both independently and in a team.

Education & Experience

• BS degree in Packaging Engineering.
• Three year's experience working with primary packaging materials, specifically those used in the pharmaceutical or health care industry.

Working Conditions

• Working conditions are in an office, laboratory and manufacturing environment. Work may require occasional weekend and/or evening work.