This Principal Engineer is a technical leader who is a member of the Commercial Device Team accountable for leading the technical aspects of combination products that enhance patient and medical professional experiences with Shire's drug delivery devices. In particular, this technical leader needs to have the experience and ability to grow the knowledge in syringe/needle devices, vial reconstitution, prefilled syringes, IV sets and/or ancillary drug delivery devices. This individual is a subject matter expert (SME) in technical, regulatory and quality issues related to commercial devices and drug delivery. Experience in rare disease applications is preferred. The successful candidate will work in a matrix environment and establish strategic working relationships with several critical line functions within Technical Operations, as well as Quality, Clinical and Regulatory Affairs. This role will have critical interaction with external Contract Manufacturing Organizations (CMOs).
This position liaises closely within Shire's product teams, along with development, DP, Packaging and within other areas of Supply Chain, Quality, Clinical and Regulatory functions.
Product and Technical Excellence: Conduct technical investigations of device needs for commercial product support for product complaints, change controls, technical aspects related to the processes and/or commercial expansion, oversight of verification and validation protocols especially as related to technology transfer, or any other technical issues related to commercial products.
Lead gap assessments / remediations as needed, and guide technical aspects of risk management activities. Lead product project plans that within budget for stated activities
Team Leadership and Effectiveness: Facilitate the evolution of the commercial device function through technical initiatives in alignment with product teams and Technical Operations- Process Development and Supply Chain.
Deliver competence and high quality decisions in areas of medical device regulations, process validation, and shelf life stability
Supplier Relationship, Compliance, Quality and Operational Excellence: Drive operational initiatives within a culture committed to operational excellence.
Lead and support on-market product interactions and expansions in the most efficient way supporting Shire globalization. Support and/or lead Continuous Improvement initiatives (including Lean Sigma/Op Excellence) on CMO Suppliers, including leading regular technical meetings.
Education & Experience Requirements
• Education: BS/MS required (MS preferred), with discipline in engineering (manufacturing, chemical, mechanical), a relevant experience or similar.
• At least 6-9 years medical device experience with biopharmaceutical industry experience
• At least 4 years of drug delivery systems and/or biopharmaceutical combination device experience, with specific experience in drug delivery devices: syringe/needle devices, vial reconstitution, prefilled syringes, IV sets and/or ancillary devices.
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.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.