Responsibilities
This position is responsible and accountable for the following
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.
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications
Doctorate degree in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field
