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

• 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.
• Lead root-cause investigations for recurring, complex, high-impact, or poorly understood equipment failures.
• Develop and optimize preventive, predictive, and condition-based maintenance strategies.
• 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.
• Lead bad-actor elimination, equipment upgrades, system modifications, and replacement recommendations.
• Lead reliability-centered improvements to single-use technology assemblies and systems.
• Provide reliability requirements for new equipment, system modifications, capital projects, commissioning, qualification, and operational readiness.
• 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.
• Perform work in accordance with cGMP, data-integrity requirements, Quality Systems, site procedures, HSE requirements, OSHA expectations, engineering standards, and approved change-control processes.

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.