Reliability Engineer

Job Description

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 Reliability Engineer is the system owner for equipment performance, operational risk, and sustainable improvement across existing manufacturing equipment, process-support systems, and selected facility assets. Reporting to the Director of Engineering, this role converts recurring failures, deviations, quality events, safety concerns, and performance losses into technically sound and measurable improvements. The Reliability Engineer leads root cause analysis, establishes asset reliability strategies, develops design and process changes, and verifies that corrective actions remain effective. 

The role partners closely with Manufacturing Engineering, Maintenance, Operations, Quality, Validation, Automation, MSAT, EHS, and Project Engineering. It is intentionally focused on eliminating systemic causes—not owning day-to-day equipment setup or serving as the primary coordinator during emergency breakdowns. 

Essential Duties and Responsibilities

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. 

Failure elimination and root cause analysis 

• Lead structured RCAs for repeat, high-risk, or high-impact equipment and process failures using appropriate 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 appropriate. 

• Define benefit assumptions before implementation and verify results after implementation, including recurrence, uptime, quality, safety, labor, scrap, and cost impacts. 

Cross-functional technical leadership 

• Partner with Manufacturing Engineering following breakdowns to determine whether formal RCA, redesign, maintenance strategy change, or other long-term action is required. 

• Provide technical direction to Maintenance for implementation of approved reliability improvements and confirm execution meets design intent. 

• Consult with Project Engineering on reliability, maintainability, accessibility, critical spares, controls, and lifecycle risks for new assets; support transition into steady-state ownership. 

• Coach engineers, technicians, supervisors, and operators in structured troubleshooting, defect elimination, and reliability fundamentals. 

• Manage vendors and contractors supporting analyses, fabrication, testing, inspection, and improvement implementation within assigned scope. 

GxP documentation and compliance 

• Create and maintain complete, accurate, and audit-ready engineering records in accordance with GDP, data-integrity, and site procedures. 

• Support development and revision of SOPs, PMs, engineering standards, drawings, equipment files, and training materials affected by reliability changes. 

• Participate in change controls, risk assessments, commissioning/qualification activities, and validation impact assessments as the engineering subject-matter expert. 

• Perform all work in accordance with applicable cGMP, EHS, quality-system, and site requirements. 

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Chemical, Manufacturing, Industrial, Reliability Engineering, or a related technical discipline.