Reliability & Methods Engineer

Role Purpose

The Reliability Engineer improves the reliability, maintainability, safety, and lifecycle performance of cGMP and non-cGMP manufacturing, utility, facility, and process systems. Using asset-performance data, risk assessments, failure investigations, predictive technologies, and maintenance history, this role identifies systemic issues and implements sustainable improvements. The Reliability Engineer leads reliability investigations, preventive and predictive maintenance optimization, CAPAs, change controls, lifecycle planning, and reliability-centered improvements to single-use technology systems.

Key Responsibilities

Asset Performance and Risk Management

• Analyze CMMS/EAM data, downtime, deviations, work orders, maintenance costs, condition-monitoring results, spare-parts usage, and equipment history.
• Develop reliability dashboards, bad-actor lists, Pareto analyses, repeat-failure trends, and MTBF/MTTR reporting.
• Assess equipment criticality and risk using FMEA/FMECA, reliability-centered maintenance, safety, compliance, product impact, redundancy, obsolescence, and business-continuity considerations.
• Recommend risk mitigation, monitoring, acceptance, escalation, or asset replacement strategies.

Failure Investigation and Problem Solving

• Lead root-cause investigations for recurring, complex, high-impact, or poorly understood equipment failures.
• Evaluate failed components, alarms, operating conditions, maintenance history, design information, and human factors.
• Investigate emerging reliability concerns, including degrading performance, repeat work orders, nuisance alarms, abnormal condition-monitoring results, and increasing parts consumption.
• Develop sustainable corrective actions and verify their effectiveness.

Maintenance Strategy Optimization

• Develop and optimize preventive, predictive, and condition-based maintenance strategies.
• Select appropriate monitoring technologies based on equipment criticality, failure modes, technical feasibility, data quality, and cost.
• Define monitoring routes, frequencies, alarm limits, response workflows, training needs, and program performance measures.
• Use risk, failure history, condition data, and field feedback to add, revise, consolidate, convert, or retire maintenance tasks through approved governance processes.

Work-Order and Inventory Analysis

• Review corrective, preventive, predictive, and emergency work orders to identify repeat failures, maintenance-induced events, planning gaps, parts usage, and opportunities to improve job plans.
• Monitor critical spares, long-lead components, repairable assets, shelf-life exposure, obsolete inventory, and stockout risk.
• Recommend stocking levels and inventory strategies based on asset criticality, consumption, lead time, redundancy, and supplier availability.

Reliability Improvement and Lifecycle Planning

• Lead bad-actor elimination, equipment upgrades, system modifications, and replacement recommendations.
• Develop technical scopes, lifecycle cost evaluations, business cases, implementation plans, and effectiveness measures.
• Lead reliability-related CAPAs and change requests for systemic or longer-term improvements.
• Support the development and execution of reliability-related capital projects and system modifications.

Single-Use Technology

• Lead reliability-centered improvements to single-use technology assemblies and systems.
• Evaluate failure modes, component selection, connection interfaces, operating limits, installation practices, leak risk, supplier performance, usability, standardization, and maintainability.
• Coordinate approved changes with Manufacturing, Process Engineering, Quality, Validation, Procurement, and suppliers.

Engineering and Project Support

• Provide reliability requirements for new equipment, system modifications, capital projects, commissioning, qualification, and operational readiness.
• Define equipment criticality, maintenance strategies, predictive-monitoring requirements, spare-parts needs, acceptance criteria, documentation, and training requirements.
• Participate in design reviews to confirm reliability, maintainability, accessibility, redundancy, control strategy, safe-work, and lifecycle requirements.

Technical Leadership and Compliance

• Develop and maintain reliability standards, tools, templates, and analytical methods.
• Coach engineers, planners, mechanics, technicians, and system owners in reliability principles, investigation methods, and data-driven decision-making.
• Maintain accurate, traceable, current, and inspection-ready technical documentation.
• Perform work in accordance with cGMP, data-integrity requirements, Quality Systems, site procedures, HSE requirements, OSHA expectations, engineering standards, and approved change-control processes.
• Support planned shutdowns, utility outages, start-ups, system restoration, emergency conditions, and manufacturing escalations.

Basic Qualifications

• Bachelor's degree in mechanical, electrical, chemical, biomedical, or related engineering discipline, with at least 3 years of relevant engineering experience in manufacturing, facilities, utilities, laboratories, or complex process equipment in a regulated or high-reliability environment.
• Candidates without a bachelor's degree must have at least 8 years of such experience.
• Applied experience with reliability methods such as FMEA/FMECA, RCM, asset criticality, MTBF/MTTR, lifecycle costing, Pareto analysis, root-cause failure analysis, and maintenance-strategy optimization.
• Experience working in a regulated environment, including cGMP and applicable OSHA and environmental requirements.
• Experience analyzing CMMS/EAM, work-order, downtime, deviation, condition-monitoring, or inventory data.
• Experience leading equipment investigations, continuous-improvement initiatives, CAPAs, or change controls.
• Working knowledge of BMS, EMS, DCS, CMMS/EAM, data-visualization tools, and Microsoft Office applications.
• Strong technical writing, communication, facilitation, coaching, and cross-functional leadership skills.

Preferred Qualifications

• Experience in pharmaceutical or biotechnology manufacturing.
• Knowledge of manufacturing equipment, utility systems, process equipment, and single-use technologies.
• Experience implementing predictive-maintenance or condition-monitoring programs.
• Experience with commissioning, qualification, validation, and equipment lifecycle management.
• Familiarity with SAP, Maximo, Infor EAM, or comparable CMMS/EAM platforms.
• Experience with Lean, Six Sigma, statistical analysis, continuous improvement, or data visualization.
• CMRP, CRL, Lean/Six Sigma, project-management, Professional Engineer, or equivalent professional certification.

Working Conditions

• Ability to gown and access manufacturing areas.
• Ability to enter operating and maintenance areas to support troubleshooting, equipment inspections, and vendor activities.
• Participation in planned site shutdowns, utility outages, system start-ups, and restoration activities.
• On-call support may be required in accordance with site requirements.