Job Description

Role- Packaging Engineer

Location-Exton, PA (hybrid) 2-3 days

Job Summary

In this role, you will be responsible for planning, organizing, and leading projects to support the development of new packaging systems and or components that enhance and preserve high value products. The ideal candidate will drive technical projects, work with cross-functional development teams, and work with strategic suppliers to develop new packaging systems. You will act as a subject matter expert for system and component packaging and drive technical decisions which support business objectives. Key responsibilities include project management, testing coordination and execution, specification / drawing development, Design History File (DHF) documentation creation and cross functional collaboration while engaging with various project teams and functional groups. As a Senior Engineer, you will be responsible for mentoring more junior engineers within the group and identifying innovative solutions to broaden portfolio. The incumbent will:

1. Demonstrate accountability for the successful and timely achievement of goals
2. Work independently only with strategic guidance in the most complex situations
3. Interpret internal and external business issues and unmet needs and take a broad perspective to define/plan/lead/develop solutions.

Essential Duties and Responsibilities

• Technical packaging lead for Integrated Systems R&D efforts related to product design and development processes from conceptualization to commercialization.
• Engage with cross-functional teams that include R&D, Pharma Processing, Marketing, Regulatory, Quality and Supply Chain to develop new packaging solutions.
• Develop innovative packaging solutions to support business growth.
• Design the packaging solutions based on various packaging and shipping standards.
• Create, Design, and execute simulation tests for the new packing and shipping solutions.
• Responsible for creation and maintenance of packaging elements for Design History File (DHF) for all assigned projects including Design Inputs, Risk Analysis (FMEAs), test protocols, and Design Verification.
• Support customers and suppliers as required for the development of new packaging solutions. Maintain effective communications and working relations with all external parties.
• Coordinate packaging testing activities for engineering studies and protocols through internal and contract packaging laboratories.
• Deliver technical reports, executive summaries, and presentations to communicate activities and timelines to management and core team members.
• Identify and drive continuous improvement efforts within the packaging group.
• Other duties as assigned.
• Maintain effective communications and working relations with all external parties.

Education

• Education or Equivalent Experience: Bachelor's in Packaging, Mechanical, Materials, or Chemical Engineering, or related engineering discipline
• Master's degree preferred

Work Experience

• Experience: 5-8 years of experience in development of packaging, medical devices, or combination products
• Previous experience in packaging development of sterile barrier systems
• Experience leading technical projects from concept through commercialization
• Experience in working under requirements of Quality Management System in a regulated environment
• Experience in communicating complex technical concepts to customers and internal stakeholders

Preferred Knowledge, Skills and Abilities

• Thorough understanding of global testing standards and regulatory requirements related to sterile barrier packaging
• Excellent interpersonal and written/verbal communication skills
• Working understanding and application of fundamental engineering principals.
• Strong technical writing abilities.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy and quality at all times.

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