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 Engineering Supervisor is responsible for overseeing engineering projects related to the design, procurement, installation, and validation of GMP manufacturing equipment at August Bioservices in Nashville, TN. This role will lead a team of project engineers, ensuring project milestones align with business objectives and regulatory requirements. The Supervisor will collaborate closely with cross-functional teams, including Facilities, Operations, and Validation, to drive project execution and continuous improvement initiatives.
Essential Duties & Responsibilities:
- Supervise and mentor a team of Project Engineers, providing technical guidance and performance management.
- Lead the planning and execution of process equipment projects, ensuring compliance with GMP standards and company policies.
- Manage project timelines, budgets, and resources to meet operational and regulatory requirements.
- Oversee the procurement, installation, commissioning, and qualification of manufacturing equipment, including aseptic filling lines, visual inspection machines, label/pack lines, ultrafiltration systems, chromatography units, mixing skids, single-use mixers, buffer prep vessels, temperature control units, and CIP skids.
- Ensure high-quality technical writing and documentation within required quality systems, including URS, FAT/SAT protocols, and engineering turnover packages.
- Coordinate and participate in FATs, commissioning, and start-up of GMP process equipment.
- Support troubleshooting and optimization of complex manufacturing equipment and processes.
- Provide SME-level support for deviations, CAPAs, and continuous improvement initiatives.
- Collaborate with cross-functional teams to support technology transfers, process development, and customer-driven projects.
- Drive process improvements to enhance equipment reliability, line efficiency, and cost reduction.
Qualifications:
- Bachelor’s degree in engineering (Chemical, Mechanical, or related).
- Minimum of 5 years of relevant experience in a GMP manufacturing or engineering role, with at least 2 years in a supervisory or leadership position (preferred).
- Strong knowledge of process equipment used in drug substance and drug product manufacturing.
- Hands-on experience with equipment validation, commissioning, and troubleshooting.
- Excellent technical writing and documentation skills.
- Strong leadership, project management, and problem-solving abilities.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint) and project management tools.
- Experience with Lean Manufacturing, Six Sigma, or other process improvement methodologies.
At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. 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.
We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!
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.
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What We Do
August Bioservices is a Contract Development and Manufacturing Organization (CDMO) headquartered in Nashville, Tennessee. August Bio offers a full range of pharmaceutical contract development and manufacturing services to pharmaceutical and biotech clients. We focus on sterile injectables, topicals, highly-complex formulations, poorly soluble & highly viscous compounds, Uncommon container sizes & fill volumes and offer aseptic and non-aseptic terminally sterilized filling of vials (liquid and lyophilized), syringes and flexible IV bags.