Reliability Engineer

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.