Reliability Engineer

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.

5 or more years of engineering experience in manufacturing, maintenance, equipment reliability, process engineering, or a related field.

Demonstrated experience leading RCAs and implementing permanent corrective actions for complex equipment or process failures.

Working knowledge of preventive/predictive maintenance, equipment criticality, FMEA, lifecycle risk, and reliability metrics.

Experience developing or implementing equipment modifications through a controlled engineering-change process.

Ability to interpret mechanical drawings, P&IDs, electrical schematics, technical manuals, control narratives, and equipment data.

Strong technical writing, data analysis, project execution, facilitation, and cross-functional communication skills.

Ability to work independently, prioritize risk, and influence execution without direct authority over partner functions.

Preferred Qualifications

Experience in pharmaceutical, biotechnology, medical-device, food, chemical, or another highly regulated manufacturing environment.

Knowledge of cGMP, 21 CFR Parts 210/211, data integrity, change control, deviation/CAPA systems, and commissioning/qualification practices.

Experience with automated manufacturing or packaging equipment, aseptic processing, clean utilities, HVAC/cleanrooms, instrumentation, PLC/HMI systems, or process historians.

Experience using a CMMS/EAM system and analyzing work-order, downtime, alarm, process, and maintenance-cost data.

CMRP, CRE, CRL, Lean Six Sigma, vibration analysis, thermography, or related certification/training.

Experience with AutoCAD, SolidWorks, statistical-analysis tools, or data-visualization platforms.

Physical and Work Environment Requirements

Regularly works in office, manufacturing, mechanical, warehouse, laboratory, and controlled environments and may be required to follow gowning and PPE requirements.

Must be able to access equipment areas, climb stairs or ladders where permitted, stand or walk for extended periods, and inspect machinery in operating and non-operating states.

May occasionally lift or move items up to 25 pounds, subject to site safety practices and reasonable accommodation.

May provide off-hours technical support during significant equipment, safety, quality, or compliance events and during planned implementation windows.

Travel is expected to be limited but may be required for vendor visits, FATs, training, or technical support.