Sr Packaging Engineer

IntePros is currently looking for a Sr. Packaging Engineer, R&D to join one of our premier medical device/manufacturing clients in Scottsdale, AZ. The Sr. Packaging Engineer, R&D will be responsible for planning, organizing and leading the packaging workstream in support of client’s Delivery Systems platform. The ideal candidate will drive technical packaging solutions for pharmaceutical customers, work with cross-functional development teams, and work with strategic suppliers to develop and improve packaging systems in accordance with Customer Development Agreements (DA) and life-cycle management (LCM). You will act as a subject matter expert for Delivery Systems packaging and drive technical decisions which support client’s business objectives. Key responsibilities include engaging with various project teams and functional groups at client to develop packaging critical to the integrity of client’s products, supporting complex supply chain and operations in the sustainment of commercial packaging, and assist with mentoring more junior personnel in your group. The individual will bring excellent analytical, engineering, and leadership talent to the Delivery Systems packaging group.

Sr. Packaging Engineer, R&D Responsibilities:

• Technical packaging workstream lead for LCM activities for various engineering projects that will allow the achievement of project goals and objectives through the implementation of new and/or improved packaging designs and processes.
• Support packaging activities associated with Customer DAs, including estimations to support proposals and task execution/assignment.
• Collaborate with cross-functional teams that include R&D, Operations, Marketing, Regulatory, Quality and Supply Chain to develop packaging solutions.
• Responsible for maintenance of packaging elements for Design History File (DHF) for all assigned projects including Clinical Packaging Development, Design Inputs, Risk Analysis (FMEAs), test protocols, and Design Verification.
• Support customers and suppliers as required for packaging-related activities. Maintain effective communications and working relations with all external parties.
• Evaluate new technologies and support equipment purchases, installation, and qualification to build and maintain the client internal packaging laboratory.
• Deliver progress reports and presentations to communicate activities and timelines to management and core team members.
• Identify and drive continuous improvement efforts within the packaging group.
• Adhere to client compliance and safety policies and procedures at all times.

Sr. Packaging Engineer, R&D Basic Qualifications:

• Education or Equivalent Experience: Bachelor's in Packaging, Mechanical, or Chemical Engineering.
• Experience: 5+ years of experience in development of packaging, medical devices, or pharmaceuticals
• Experience leading technical packaging workstreams from concept through commercialization.
• Experience in working under requirements of Quality Management System in a regulated environment.
• Working understanding and application of capturing product / packaging requirements for packaging and labeling, designing, and testing packages, that meet the internal requirements and comply to ISO 11607 standard.
• Thorough understanding or global testing standards and requirements related to sterile barrier packaging.
• Understanding of fundamental engineering principles and prior experience with packaging design, materials, manufacturing processes, and test methodology required.
• Ability to work independently as a Subject Matter Expert (SME) and mentor/lead less senior team members.

Sr. Packaging Engineer, R&D Preferred Knowledge, Skills and Abilities:

• Master’s Degree in related field.
• Previous experience in packaging development of sterile barrier systems.
• Knowledge about different packaging material configurations, applications, and properties (Foil, Tyvek, Films, Nylon, breathable vs. non breathable sterile barrier systems, etc.).
• Knowledge of pharmaceutical labeling development and packaging regulatory submission support.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Previous experience with cold chain packaging development and specialized supply chain shipping qualifications.

Travel Requirements:

• Must be able to travel up to 15% of the time

Physical and Mental Requirements:

• Must be able to occasionally lift product boxes (up to 25 lbs.) for sample preparation

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