Sr Packaing Engineer, R&D

 

This is an hybrid position in Scottsdale, AZ. It is NOT a remote role. Candidates applying to this role must be residing within a 50 radius to the job location.

 

Who We Are:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

 

Job Summary:

In this role, you will be responsible for planning, organizing and leading the packaging workstream in support of West’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 West’s business objectives.  Key responsibilities include engaging with various project teams and functional groups at West to develop packaging critical to the integrity of West’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.

 

Essential Duties and 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 West 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 West compliance and safety policies and procedures at all times.

 

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.

 

Preferred Knowledge, Sk