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Packaging Engineer

Company:
LanceSoft Inc.
Location:
North Haven, Connecticut, 06473, United States
Posted:
November 05, 2018

Description:

Sr. Packaging Compliance Engineer

Years of Experience Required: 5-7 (med device packaging)

Must Haves:

• Packaging Experience

• Medical Device Industry

• Quality/Compliance Experience

Be part of the dynamic team to bring expertise in the areas of quality, regulatory compliance, identification and procurement of new packaging machinery and packaging documentation. Identify, design, develop and evaluate innovative packaging processes as part of a cross functional new product development team. Senior Packaging Compliance Engineer will be frequently assigned leadership responsibility for entire projects including:

• Utilize quality and regulatory compliance expertise to support regulatory body audits, draft technical responses and provide innovative ideas to ensure compliance to latest industry practices.

• Perform Gap Analysis of existing documents (Ship Testing, Aging studies, and process validations) to latest standards such as ISO11607 Part 1 and 2.

• Lead project meetings and provide updates to management

• Provide Providing technical expertise and project support to new product development teams by consulting within areas of packaging materials and equipment.

• Identifying and supporting the purchasing of new packaging equipment.

• Preparation of capital expenditure requests, drawings and specifications for new processes and equipment.

• Assisting in artwork creation and revisions for product packaging.

• Performing packaging validation testing to support new product development.

• Testing new packaging methods and processes using various testing apparatus in qualification of packaging changes

Must Have: Minimum Requirements

• BS Degree in Packaging Science, Mechanical Engineering or equivalent with minimum of 5 years’ combined experience in Packaging and Quality Engineering.

• Proven track record preparing written policies, procedures, proposals and reports.

• Knowledge of ASTM and ISTA package test methods is required.

• Knowledge of Microsoft Office programs is required.

• CAD programming knowledge is required.

• Strong team and interpersonal skills

Nice to Have: Preferred

Medical device, pharmaceutical or related industry preferred.

Strong leadership skills. Ability to mentor and coach others

Broad knowledge of Mechanical/Manufacturing Engineering