Reliability Engineer

Overview

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!

• Reliability strategy and asset performance:
  Develop and maintain reliability strategies for critical assets based on equipment criticality, failure history, product/process risk, and lifecycle stage.
• Establish asset performance baselines and monitor availability, reliability, maintainability, downtime, repeat failures, and chronic loss drivers.
• Build and maintain equipment criticality assessments, bad-actor lists, reliability roadmaps, and risk-ranked improvement backlogs.
• Support asset lifecycle decisions, including repair-versus-replace analyses, obsolescence planning, spare-parts strategy, and capital recommendations.
• Leadership of root cause analysis for repeat, high-risk, or high-impact equipment and process failures using methods such as 5-Why, fault-tree analysis, fishbone, FMEA, and data trending.
• Translate event evidence into defensible failure mechanisms, corrective actions, owners, due dates, and measurable effectiveness criteria.
• Identify common-cause and systemic issues across assets rather than treating failures as isolated work orders.
• Provide technical support to investigations, deviations, CAPAs, audit responses, and quality or safety events involving equipment performance.
• Design, process, and workflow improvement:
  Serve as design authority for modifications to existing equipment within delegated scope, including mechanical, controls, instrumentation, guarding, utility interface, and workflow improvements.
• Develop technical scopes, engineering calculations, drawings, specifications, risk assessments, and acceptance criteria for reliability improvements.
• Lead process and process-flow optimization when equipment design, system interaction, workflow, or risk controls must change.
• Ensure modifications are evaluated and implemented through applicable change-control, validation, commissioning, documentation, and training processes.
• Confirm that improvements do not adversely affect validated state, product quality, data integrity, operator safety, cleanroom performance, or regulatory compliance.
• Maintenance and condition-based reliability:
  Optimize preventive maintenance tasks and frequencies using failure modes, work-order history, OEM guidance, inspection results, and risk—not calendar frequency alone.
• Develop predictive and condition-monitoring approaches where justified, including vibration, thermography, oil analysis, motor-current analysis, ultrasound, calibration drift, and process-variable trending.
• Define maintenance job plans, precision-maintenance requirements, lubrication standards, alignment/balancing expectations, and post-maintenance acceptance checks with Maintenance.
• Evaluate spare-parts criticality, bills of material, min/max levels, component standardization, and obsolescence risk with Maintenance and Supply Chain.
• Data, metrics, and continuous improvement:
  Use CMMS, automation, historian, alarm, batch, quality, and production data to identify trends and quantify losses.
• Develop Pareto analyses and reliability dashboards that make repeat failures, downtime, maintenance effectiveness, and improvement progress visible.
• Facilitate cross-functional improvement efforts using Lean, Six Sigma, and reliability-centered problem-solving principles as…