Principal Engineer, Packaging – Technical Services

Role Overview

• 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 associated structure technical data for assigned projects.
• Create all specifications required for the container/closure systems for assigned projects.
• Create all associated aggregation/serialization requirements 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.
• Support other Technical Service Packaging Engineers with peer review; as well as, provide appropriate mentoring.
• Influence and Collaborate with Purchasing to source new packaging components, if needed.
• Interact with outside vendors to design new packaging components.
• Influence and Liaise with Change Management to support packaging component changes.
• Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.
• Influence and Liaise with Flow Packaging group to ensure consultation of launch projects for efficient transfer of applicable projects for life cycle transfer.
• Drive continuous improvement activities for launched products through initial commercial production phase, until transfer of launched products to lifecycle support with Operations.

Requirements

• 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.
• Alternatively, a 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.
• Alternatively, a 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.
• (Internship or co-op programs may qualify for work experience for those with Ph.D. degrees.)
• 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 (e.g. modified/extended release, nasal suspensions, soft gels, bead/pellet coated products, film coated products, and/or novel delivery systems).
• Experimental Methodology: Subject Matter Expertise in experimental methodology and ability to design complex experiments to support pharmaceutical packaging development.
• Proficiency in the use of statistical software for experimental design and analysis is preferred but not required.
• Critical Thinking/Complex Problem solving: Ability to apply the PDCA principles (plan, do, check, act) and develop solutions for a variety of problems.
• Computer Skills: Expert computer skills with the ability to enter data into and retrieve information from various software programs such as Microsoft Office (Work, Excel, PowerPoint, and Outlook) and SAP.
• Mentoring / Coaching: Strong ability to coach and/or mentor both in and out of reporting structure (e.g. mentoring junior Process Engineers, providing guidance to production Coaches and Technicians regarding optimization opportunities).

Benefits

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay.
• Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).
• Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave