Project Engineer

August Bioservices, LLC; Nashville (TN); On-site; USD 70,000 - 90,000; Full time

Job summary

August Bioservices, LLC in Nashville, TN is seeking a Project Engineer to ensure the operability and reliability of GMP manufacturing process equipment. The role involves supporting equipment procurement, completing project tasks, and participating in various engineering phases. Candidates must have a Bachelor's in a related field, minimum 2 years of relevant experience, and strong technical writing and interpersonal skills. This position offers an exciting opportunity to contribute to global health and participate in a growth-focused environment.

Qualifications

• 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.

Responsibilities

• Provide engineering support for process equipment procurement and start-up.
• Drive results by owning and completing projects including technical writing.
• Participate in project teams through all phases of engineering projects.

Skills

Project management

Technical writing

Interpersonal communication

Problem solving

Education

Bachelor’s degree in Chemical Engineering, Mechanical Engineering or related

Tools

Excel

Word

PowerPoint

Job description

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). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase 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 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 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 to 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.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.