Principal Engineer, Packaging – Tech Services

Responsibilities

• Responsible for transferring products from R&D or partners to Operations, including leading packaging development, registration, site transfers, start-up of commercial production, and transfer to lifecycle support.
• Minimize and remove obstacles during development, product transfer, validation, and commercialization through utilization of risk‑mitigation strategies, best practice sharing, and influence with R&D, Operations, and external colleagues.
• Support department management as group representative in technical and business meetings.
• Act as a technical subject matter expert and mentor for the Technical Services group and the site.
• Demonstrate influence, leadership, and influential teamwork skills with development partners/customers during the packaging development and registration of site transfers and new product NDAs and ANDAs, ensuring that all project timelines are met.
• Provide packaging engineering expertise, i.e. critical review, assessment, influence and strategy, for responsible projects assigned within Organic Launch, Business Development, Contract Manufacturing Organization (CMO), Alternate API, and targeted dormant products.
• Create all associated master data for assigned projects.
• Create all specifications required for the container/closure systems for assigned projects.
• Attend all required team meetings to support assigned projects and ensure to achieve key milestone datas.
• Perform all necessary line trials, including all necessary documentation such as protocols/reports/PO’s, to support proper evaluation of form, fit, function of proposed container closure systems.
• Support all regulatory audits as required. Generate all required regulatory submission documents for assigned projects and provide support in generating responses to regulatory authorities.
• Drive continuous improvement activities for launched products through initial commercial production phase, until transfer of launched products to lifecycle support with Operations.

• B.S. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of 15 years of experience in pharmaceutical technology transfer, quality assurance, product development, packaging, or applicable pharmaceutical experience, or seven years of experience in product development, technology transfer, and/or packaging engineering in another technical field.
• M.S. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of 13 years of experience in pharmaceutical technology transfer, quality assurance, product development, packaging, or applicable pharmaceutical experience, or five years of experience in product development, technology transfer, and/or packaging engineering in another technical field.
• Ph.D. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of 10 years of experience in pharmaceutical technology transfer, quality assurance, product development, packaging, or applicable pharmaceutical experience, or two years of experience in product development, technology transfer, and/or packaging engineering in another technical field.
• Demonstrated ability to perform at expectations for the following Hikma competencies:
  Collaboration & Teamwork, Communication & Influence, Customer Focus, Planning & Organization, Taking Initiative & Drive For Results.
• Expert knowledge and understanding of applicable laws and regulations regarding development and packaging of pharmaceuticals, including cGMP, DEA, and FDA guidances.
• Demonstrated technical knowledge of pharmaceutical packaging environment and equipment with emphasis on scale-up/ optimization and validation for various dosage forms.
• Proficiency in the use of statistical software for experimental design and analysis is preferred but not required.