This Sr. Principal Engineer is a technical leader who is a member of the Commercial Device Engineering Team that is accountable for leading the technical aspects of commercial reconstitution and drug delivery devices that enhance patient and medical professional experiences with Shire’s immunology and hematology products. In particular, this technical leader needs to have the experience and ability to grow the knowledge in reconstitution devices, IV sets and 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 such as immunology and/or hematology 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 interactions with external Contract Manufacturing Organizations (CMOs). Experience in manufacturing processes and aspects of project manufacturing are required.
This position liaises closely within Shire’s product teams, along with device development, Drug Product, Packaging and other areas of Supply Chain, Device Quality, Clinical and Regulatory functions.
Responsibilities (% of time):
Product and Technical Excellence: Conduct technical oversight of commercial device for technology transfer, manufacturing robustness, commercial expansion, verification / validation protocols / reports with technical investigations. Have experience to support processes for regulatory filings, product complaints, change controls and other device quality related processes.
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 engineering function through technical initiatives in alignment with product teams and Technical Operations-Process Development. Support Supply Assurance to deliver high quality device products. Collaborate on 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. Support and/or lead Continuous Improvement initiatives (including Lean/6Sigma/Op Excellence) on CMO Suppliers, including internal and external technical meetings. Lead and support on-market product interactions and expansions in the most efficient way supporting Shire globalization.
• Education: BS/MSrequired (MSpreferred), with discipline in engineering (manufacturing, chemical, mechanical), a relevant experience or similar.
• At least 10-12 years medical device experience with biopharmaceutical industry experience
• At least 6years of drug delivery systems and/or biopharmaceutical combination device experience, with specific experience in reconstitution devices, IV sets and/or drug delivery devices.
Req ID: R0018837