Job Description
Summary/Purpose of Position High level technical position requiring application of extensive technical knowledge to independently lead the design of complex packaging systems in support of:
- Development and commercialization of new products and line extensions
- Manufacturing maintenance-of-business activities
- Cost Improvement Programs
Additional responsibilities may include project leadership and mentorship/supervision of junior level engineers and co-ops.
Essential Duties and Position Responsibilities Support new product team and line extension activities including:
- Concept development
- Project Plans/Schedules
- Design reviews and design for manufacturability
- Development of test plans
- Development of prototype packaging/tooling
Plan and coordinate all activities to launch and commercialize new products and line extensions including:
- Concept and development of packaging methods and processes
- Coordination of all new tooling and equipment
- Coordination of labeling
- Development and release of all new product and process documentation including design control documentation
- Creation of all relevant test protocols and technical reports
- Planning, ordering and coordination of all new component inventory
- Qualification and validation of all new components, equipment, processes and operations
- New product cost estimates for packaging
- Preparation of AFE(s)
- Evaluation and recommendation of new materials
Plan and coordinate all packaging engineering activities to transfer new products and line extensions to manufacturing including:
- Development and management for packaging requirements of the transfer plan
- Development and release of all packaging documentation
- Creation of all relevant test protocols and technical reports
Provide packaging engineering support to manufacturing including the following:
- Assessment and development of action plans to overcome packaging related manufacturing issues
- Support of cost improvement programs and manufacturing improvement plans related to product packaging
- Audit support
Provide technical leadership for:
- Technical initiatives, CAPA resolutions, compliance projects
- Due diligence teams to support New Business Development/acquisition teams
Qualifications, Knowledge, and Skills Required: - B.S. degree in Packaging Engineering/Packaging Science, Life Sciences or other Engineering discipline required, with a minimum of eight (8) years in packaging engineering and design, or M.S. degree in Packaging Engineering/Packaging Science, Life Sciences or other Engineering discipline required, with a minimum of six (6) years relevant experience
- Experience in the medical device or pharmaceutical industries preferred.
- Ability to handle a variety of assignments at the same time.
- High level of written and verbal communications skills. Ability to write and independently analyze results of technical reports.
- Knowledge of FDA and functional requirements for sterile, non-sterile, disposable and reusable devices.
- Ability to conceptualize ideas, motivate and focus individuals and teams and drive projects through to completion on time and on budget.
- Broad knowledge of properties for materials utilized in primary and secondary packaging, plus packaging methods and equipment.
- Working knowledge of package test methods, process validation, bar coding and international standards.
- Some travel required as needed to support projects
PackStaff, LLC
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