Hikma Plc-posted 2 months ago
Full-time • Senior
Columbus, OH

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. We are seeking a talented and motivated Principal Engineer, Packaging - Technical Services to join our team. In this role, you will be 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.
  • Represent Technical Services in the development and filing of new products.
  • Influence and Collaborate with Purchasing to source new packaging components, if needed.
  • Interact with outside vendors to design new packaging components.
  • Develop packaging material specifications for new packaging components for internal projects (R&D) and external customers (BD, transfers).
  • Provide independent critical review of new products/packaging regarding fit with operational capabilities.
  • Provide feedback to product development or partners on potential critical mismatches between new products/packaging designs and operational capabilities.
  • Lead and Influence product development or partners in the selection and/or design of packaging which meet product and regulatory requirements.
  • Create documentation based on process design parameters mutually agreed upon with product development or partners.
  • Perform peer review of documentation to drive right-first-time performance of department.
  • Execute assigned project deliverables with limited to no consultation with functional management for highly complex challenges.
  • Drive highly effective Risk Assessment processes at applicable development and launch gates.
  • Influence and Liaise with Drug Regulatory Affairs (DRA) to support documentation required for product filing.
  • Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.
  • Lead Packaging Risk Analysis and Line Trials for new products as the Technical Services representative.
  • Collaborate with and influence product development or partners during site transfer, scale-up and validation production and packaging.
  • Provide around-the-clock technical support to production.
  • Lead functional and cross-functional investigations to determine root causes, assess product impact, determine path forward, and develop/implement CAPAs.
  • Drive packaging, process, and specification improvements.
  • Prepare line trial protocols/reports, packaging material specifications, SAP master data, master packaging specifications.
  • Drive continuous improvement activities for launched products through initial commercial production phase.
  • Mentor and develop other members of the Technical Services department.
  • 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.
  • 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.
  • 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.
  • Expert knowledge and understanding of applicable laws and regulations regarding development and packaging of pharmaceuticals, including cGMP, DEA, and FDA guidances.
  • Demonstrated knowledge of pharmaceutical packaging environment with emphasis on scale-up/optimization and validation.
  • Demonstrated technical knowledge of pharmaceutical packaging equipment.
  • Demonstrated knowledge of packaging development.
  • Ability to successfully develop and/or transfer pharmaceutical packaging processes for challenging dosage forms and/or processes.
  • 10+ years commercial molding experience.
  • Experience with systems such as SAP, TrackWise, Veeva or a Manufacturing Execution System (MES).
  • Annual performance bonus, commission, and share potential.
  • Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.
  • A generous paid time off (PTO) bank starting with 20 days.
  • 3 personal days.
  • 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.
  • Career advancement and growth opportunities.
  • Tuition reimbursement.
  • Paid maternity and parental leave.
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