Reliability Engineer in Nashville, Tennessee at August Bioservices

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.