Senior Packaging Engineer

This position applies physics, engineering and chemistry principles coupled with advanced and diverse materials science understanding and principles to assist in the evaluation, design, qualification and implementation of packaging components and the associated systems such as documentation, equipment and processes. A knowledge of common materials used in pharmaceutical packaging is key to this role.

This role will support Amgen's manufacturing network by applying broad knowledge of pharmaceutical packaging operations, equipment, devices, and materials to develop the industry's best combination product assembly and packaging processes. Understanding of packaging manufacturing equipment and processes and how materials interact with these are essential to the position.

The job will require both planning and technical support of complex projects supporting a new site start-up. This role will be responsible for planning and coordinating projects to ensure on-time completion, establish priorities, report project status updates, and manage project dashboards for the Secondary Packaging Engineering team.

Responsibilities

• Provide technical support for secondary packaging materials and processes, and share expertise with cross-functional teams.
• Evaluate, recommend, and select secondary packaging materials for pharmaceutical products.
• Assess complex material and process problems, identify root causes, and recommend and implement solutions.
• Write test protocols and technical specifications; perform technical evaluations and prepare assessment reports to support the use of selected materials.
• Plan and support packaging trials and characterization, including defining objectives, test materials and quantities, acceptance criteria, and documentation needs.
• Support technology transfer of packaging components and processes from clinical to commercial use or from site to site.
• Manage assigned projects and help coordinate the work of entry-level engineers and contingent workers.
• Set clear expectations, track responsibilities and due dates, and provide technical guidance.
• Set priorities and monitor project milestones, risks, and deliverables to keep work on schedule and meet quality expectations.
• Lead and present new packaging ideas, concepts, and designs to the Product Development team; represent FPA and Final Product Technologies, as required.
• Ensure work follows cGMP, regulatory, site, and safety requirements.
• Support change controls in partnership with Quality Assurance and Regulatory, and participate in Pre-Approval Inspections (PAIs) or interact with regulatory bodies as needed.
• Collaborate with cross-functional teams, including Research, Quality, Supply Chain, Maintenance, Manufacturing, Regulatory, and Process Development, across pre-commercial and commercial activities.
• Use data and feedback to identify trends, explain technical issues clearly, and recommend improvements to packaging processes.

Basic Qualifications

• Doctorate degree in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field
• Or Master's degree in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 2 years of Packaging Engineering experience
• Or Bachelor's degree in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 4 years of Packaging Engineering experience
• Or Associate's degree in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 8 years of Packaging Engineering experience
• Or High school diploma / GED & 10 years of Packaging Engineering experience

Preferred Qualifications

• Master's degree in Packaging Engineering, Materials Science, Pharmacology, Mechanical Engineering, Chemical Engineering, or related engineering field
• 7+ years of packaging engineering experience with 4+ years within the Pharma/Bio industry
• Leading technical teams
• Independent thinker with demonstrated skills working in teams or leading technical project teams
• Strong Interpersonal and communication skills
• Project management
• Ability to manage competing priorities