Project Engineer

The Project Engineer is responsible for ensuring operability and reliability of GMP manufacturing process equipment located at August Bioservices manufacturing site in Nashville, TN. This individual will work with closely with Facilities, Operations and Validation groups to design and commission process equipment.

Responsibilities

• Provide engineering support for process equipment procurement and start-up at August Bioservices. This includes our Aseptic Filling Lines, Visual Inspection Machines, Label/Pack Lines, Ultrafiltration, Chromatography, Mixing Skids, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Clean in Place Skids, etc..
• Drive results by owning and completing the subsequent projects including high quality technical writing within the required quality systems and meeting the project timelines to ensure the start-up schedule is not impacted.
• The Project Engineer will participate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.
• Work with cross-functional teams for the design of equipment, consumables, and components, initiating and maintaining vendor relationships to meet design and construction timelines, and drive project schedules to meet milestone deliverables.
• Review design documentation from conceptual through detailed design, URS documents, and Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.
• Participate in FATs, Commissioning and Start-up of process equipment related to manufacturing operations
• Provide troubleshooting for complex manufacturing equipment including formulation, fill/finish, packaging/inspection and serialization lines
• Experience interfacing with customer driven projects including tech transfer programs and process development
• Provide SME knowledge for CAPA and deviations that occur during the manufacturing process
• Support continuous improvement projects to increase line efficiency and reduce operating costs

Desired Attributes

• A bachelor’s degree in Chemical Engineering, Mechanical Engineering or related
• Minimum of 2 years relevant experience as a Process Engineer or similar function
• At least 2 years of experience in a GxP environment preferred
• Experience with Drug Substance and Drug Product Equipment (Aseptic Filling Lines, Visual Inspection Machines, Label/Pack Lines, Ultrafiltration, Chromatography, Mixing Skids, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Clean in Place Skids, etc.)
• Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions.
• Technical writing skills required.
• Must be able use his/her technical background to make informed project decisions and ensure timelines are met.
• Familiarity with Excel, Word, and PowerPoint are required.
• Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.
• Ability to represent August Bioservices’ interests, objectives, and policies in a professional and responsible manner.