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Principal Engineer, Packaging – Tech Services
Hikma PharmaceuticalsPrincipal Engineer, Packaging at Hikma Pharmaceuticals responsible for product transfers and packaging development. Collaborating with R&D and Operations to ensure successful project execution and regulatory compliance.
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
packaging developmenttechnology transferproduct developmentquality assurancepackaging engineeringregulatory submissionrisk-mitigation strategiesstatistical softwarecGMPvalidation
Soft Skills
leadershipinfluential teamworkcommunicationcollaborationcustomer focusplanningorganizationinitiativedrive for resultsmentoring