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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 causesnot owning day-to-day equipment setup or serving as the primary coordinator during emergency breakdowns.
Reliability strategy and asset performance
Develop andmaintainreliability strategies for critical assets based on equipment criticality, failure history, product/process risk, and lifecycle stage.
Establishasset performance baselines andmonitoravailability, reliability, maintainability, downtime, repeat failures, and chroniclossdrivers.
Build andmaintainequipment 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 usingappropriate methodssuch 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.
Identifycommon-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
Serveasdesignauthority for modifications to existing equipment withindelegatedscope, 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
Optimizepreventive maintenance tasks and frequencies using failure modes, work-order history, OEM guidance, inspection results, and risknot 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.
Definemaintenancejob 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,componentstandardization, and obsolescence risk with Maintenance and Supply Chain.
Data, metrics, and continuous improvement
Use CMMS, automation, historian, alarm, batch, quality, and production data toidentifytrends and quantify losses.
Develop Pareto analyses and reliability dashboards that make repeat failures, downtime, maintenance effectiveness, and improvement progress visible.
Facilitatecross-functional improvement efforts using Lean, Six Sigma, and reliability-centered problem-solving principles asappropriate.
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 todeterminewhether formal RCA, redesign, maintenance strategy change, or other long-term action isrequired.
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.
GxPdocumentation and compliance
Create andmaintaincomplete,accurate, and audit-ready engineering recordsin accordance withGDP, data-integrity, and site procedures.
Support development and revision of SOPs, PMs, engineering standards, drawings, equipment files, and training materials affected by reliability changes.
Participatein change controls, risk assessments, commissioning/qualification activities, andvalidationimpact assessments as the engineering subject-matter expert.
Perform all workin accordance withapplicable cGMP, EHS, quality-system, and site requirements.
Bachelor’s degree in Mechanical, Electrical, Chemical, Manufacturing, Industrial, Reliability Engineering, ora relatedtechnical discipline.