Senior Packaging Engineer for Sterile Drug Products

3 weeks ago

Nashville, Tennessee, United States August Bioservices Full time

About the Role

We are seeking a highly skilled Packaging Engineer to join our team at August Bioservices. As a key member of our Technical Operations department, you will be responsible for developing, implementing, and maintaining primary and secondary packaging material specifications for assigned projects.

Key Responsibilities

  • Lead and own responsibility for developing, implementing, and maintaining primary and secondary packaging material specifications for assigned projects.
  • Collaborate with project stakeholders and supply chain to establish approved vendors for supply of packaging and labeling materials for both R&D and GMP applications.
  • Lead design of packaging and labeling configurations for vials, pre-filled syringes, IV bags, and bottles for distribution to clinical trials and commercial markets around the globe.
  • Collaborate with key stakeholders to assure recommended packaging and labeling is compatible with client drug products.
  • Review client and vendor provided packaging materials and drawings.
  • Assure an appropriate stock of packaging and labeling materials aligned with currently supported product dosage forms/sizes is maintained for use in R&D and clinical trial applications.
  • Support Technical Operations team as required in the development and execution of R&D and Engineering Studies including protocol development.
  • Provide key opinion in support of packaging and labeling validation studies, investigations for packaging failures, and best practices for packaging design and shipping/distribution studies.
  • Support Project Engineers to conduct packaging equipment design, selection, qualification, and validation.
  • Coordinate product package testing with appropriate vendors in accordance with FDA/EMA regulations.
  • Perform FMEA as required in support of packaging design specifications.
  • Consult with and provide technical assistance to Research and Development, Manufacturing, Supply Chain Management, and Quality Assurance teams both internal and external.
  • Supervise and conduct the shipment or simulated shipment testing of all packaging as required and evaluate the results of such tests.
  • Recommend and conduct cost reduction studies to reduce package material costs or effect packaging changes that result in higher production line speeds, greater efficiency, less waste, and reduction in labor requirements.
  • Provide support for establishment and maintenance of secondary packaging capabilities as they relate to commercial 'track and trace' operations.
  • Support peer review of protocols, data reports, and Master Batch Records as assigned.
  • Investigations and Corrective Actions analysis and support as required.
  • Mentor other team members to develop skills and expertise.
  • Troubleshoot and resolve complex issues, diagnosing technical problems and identifying short and long-term solutions.

Requirements

  • B.S. in a relevant Engineering field (Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering) or Packaging Sciences or Chemical Engineering (or equivalent relative engineering degree) with 7+ years of relevant experience.
  • Alternatively, the candidate requires M.S. in Packaging Sciences or Chemical Engineering (or equivalent relevant engineering degree) with 5+ years of relevant experience.
  • Knowledge of pharmaceutical packaging standards and testing protocols.
  • Knowledge typical suppliers and materials for vial, pre-filled syringe, and flexible IV bag primary containers.
  • Knowledge of typical materials and approaches to sterile drug product secondary packaging and labeling.

About August Bioservices

We are a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO) headquartered in Nashville, TN. We provide a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow.

We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred, and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

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