Shire Principal Device Development Packaging Engineer in Lexington, Massachusetts

Responsible for applying advanced principles of packaging technology and engineering in the independent initiation and execution of technical packaging designs for combination products. This position is to develop innovative new packaging concepts, qualify and implement optimal and cost-effective packaging design solutions that offer best in class process efficiency to operations in the different Shire sites and CMO, including marketing and regulatory requirements. This role will be working very closely with the packaging engineering group to coordinate packaging design and development effort and responsible for the transfer the commercial packaging group.

This role will also be involved in the development and launch of secondary and/or, tertiary packaging components. The candidate will assess, develop, design, specify, test and implement packaging projects at external and/or internal manufacturing packaging sites. Additional responsibilities include leading in package trial runs, project start-ups (FATs/SATs), and resolving manufacturing issues.

Responsibilties (% of time):

40%

  • Develop innovative new packaging concepts, qualify and implement optimal and cost-effective packaging design solutions

  • Manage packaging design activities by designing, developing, qualifying and implementing secondary and tertiary packaging solution.

  • Lead, manage and execute all aspects of a project. Accountable for delivering on specific performance indicators, including but not limited to:

  • Packaging Component Specifications, Bill of Materials, Technical Protocols and feasibility testing

  • May be the Process Owner and /or the Execution Lead, for one or more processes, including but not limited to:

  • New Technology Acquisition

  • New Package Introduction

  • Combination Product and Device Packaging

  • Packaging & Art-Work Specifications

  • Packaging Process Development

  • Demonstration kit and starter kit

30%

  • Will work with internal packaging stakeholder to create or enhance packaging capabilities to deliver the needed quality required by our patients.

  • Will partner with packaging engineering group to ensure quality in product packaging and drive elimination of customer complaints relating to packaging.

  • Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers, Contract packagers, Product Strategy Leads, Quality Assurance, Procurement, Business Development, Research and the Brand Teams.

15%

  • Serve as a Package Engineer to the Product Technical Teams

  • Support protocols development for the feasibility testing

  • Support and lead labeling change process by evaluating the impact on packaging material and on the packing operations.

15%

  • Recruit and manage external resources, such as, Consultants and Contractors, as needed to deliver projects.

  • To remain current with developments in their respective specialization or practice by actively engaging in and participating in professional organizations.

  • Represents device development and external manufacturing on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations and other internal or external customers on new and existing products introductions.

  • Investigate new sources and make recommendations on packaging materials and support material change and implementation.

  • Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, risk-management based solutions to complex technical challenges.

Requirements:

  • Requires a Bachelor’s degree in a scientific/technical discipline with a minimum of 8 years related experience. Applies expert knowledge of scientific/technical principles & concepts in managing technical programs such as:

  • Technology acquisition

  • Equipment qualification

  • Package design development for secondary and tertiary packaging system

  • Technology transfer

  • Qualification of packaging components

  • Experience in global product launches and the associated CMC regulatory requirements.

  • Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and DEA Regulations is preferred.

  • Demonstrated ability to simultaneously manage multiple projects of variable complexity.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.