Job Description

Position Scope: The Packaging Engineer is responsible for the design, validation and implementation of packaging materials, packaging equipment and systems. The position interfaces with all departments to ensure materials and processes are compatible for technology transfer and consistent with established project plans and corporate goals. All activities are performed according to internal Quality System requirements, cGMP and ISO 13485 standards. Strategic Focus Areas: Maintain all activities to meet project timelines. Maintain effective collaboration with internal colleagues and external vendors to meet corporate objectives and drive business results. Maintain cost discipline within assigned programs. Specific Tactical Responsibilities: Collaborate with packaging material vendors to evaluate and select cost effective packaging materials that meet industry standards for sterile barrier packaging systems (if required) Manage capital projects including design, purchase, validation and implementation of equipment and packaging processes to meet project schedule and budgetary requirements Interact with multiple departments internally and external vendors to coordinate multidisciplinary tasks Identify calibration requirements and tolerances for new equipment and instruments Prepare draft-operating procedures for new equipment and processes and works with Document Control to ensure final processes are implemented through the document mastering process Develop/edit master part specifications and/or artwork specification to meet regulatory and marketing requirements Perform process/product risk assessments and prepare reports according to company procedures Prepare equipment (IOQ, PQ) and process validation (PV) protocols Coordinate activity with the Packaging Department to execute equipment and process validations according to approved protocols Generate discrepancy/deviation and validation summary reports documenting results of validation activities Responsible for other duties and projects as assigned Job Complexity: The position works on problems of technical scope requiring critical thinking and interaction with internal and external technical professionals. The position exercises broad judgment within generally defined practices and policies. Supervisory Responsibilities: None; must be able to participate in and lead multi-disciplined project teams and manage vendors, contractors and consultants as required. Required Qualifications: Bachelor's degree in in Packaging Technology, Mechanical Engineering or related field or equivalent experience. Experience in a cGMP regulated environment Experience with medical device packaging equipment and processes Demonstrated experience with material, equipment, and process validation according to pharmaceutical and medical device industry standards Desired Experience, Knowledge, and Skills: Master's Degree in Mechanical or Packaging Engineering Previous experience with sterile barrier packaging systems Experience with a heat sealing, cartoning, and on-line barcode printing and coding Demonstrated project management experience Excellent equipment and process troubleshooting skills Ability to work autonomously, effectively manage time and deliver results on time Excellent presentation skills, both written and in platform presentation format Anika Therapeutics

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