Senior Packaging Engineer, Sterile Drug Products

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). To support our growth plans, August has invested significant capital in an expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August! The role will have the opportunity to work with cutting edge pharmaceutical processing technologies in support of a critical business core competency.
August Bioservices is seeking a Packaging Engineer focusing on sterile drug product primary and secondary packaging reporting to the Sr. Director of Technical Operations. The candidate will serve as a packaging development expert for aseptic product design and is a core team member for customer facing collaborations. An understanding of pharmaceutical product packaging/labeling design and selection of primary and secondary for optimal product shelf-life is required. Technical understanding and application of current equipment, and process controls is an important competency as they relate to manufacturability of selected primary and secondary packaging materials. Central to the role is ownership of selected packaging/labeling designs, maintenance of required materials and components and testing of packaging performance in alignment with client requirements.

Responsibilities

• Leads and owns responsibility for developing, implementing, and maintaining primary and secondary packaging material specifications for assigned projects providing the basis for the purchasing and planning of packaging materials procurement.
• 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
• Assures 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.
• Supports Technical Operations team as required in the development and execution of R&D and Engineering Studies including protocol development.
• Provides key opinion in support of packaging and labeling validation studies, investigations for packaging failures and best practices for packaging design and shipping/distribution studies.
• Supports Project Engineers to conduct packaging equipment design, selection, qualification and validation.
• Coordinates product package testing with appropriate vendors in accordance with FDA/EMA regulations which includes but is not limited to CFR, ISTA, EP and USP
• Perform FMEA as required in support of packaging design specifications
• Consults with and provides technical assistance to Research and Development, Manufacturing, Supply Chain Management and Quality Assurance teams both internal and external.
• Supervises and conducts 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.
• Provides 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
• Proficient in quality system software such as Master control and related task such MOC (change control), CAPA, Issue Reviews, Work Orders, collaboration, and approval of various documents. 

Skills & Education

• B.S. in in a relevant Engineering field (Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering) Packaging Sciences or Chemical Engineering (or equivalent relative engineering degree) with 7+ years of relevant experience
• Alternatively, the candidate requires M.S. in Packagi