{"id":1330320,"url":"https://alion.io/job/august-bioservices-sterile-injectable-cdmo-reliability-engineer","title":"Reliability Engineer","company":{"id":3783650,"name":"August Bioservices","domain":"augustbio.com","url":"https://alion.io/company/augustbio","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"C","score":63,"open_postings":24,"ghost_share":0.625,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":53,"computed_at":"2026-10-20T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Nashville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":86000,"max_usd":162000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5966},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"AutoCAD","optional":true},{"name":"CAPA","optional":true},{"name":"SolidWorks","optional":true}],"status":"live","first_seen_at":"2026-07-17T20:03:36Z","employer_posted_date":"2026-07-17","last_verified_at":"2026-10-21T03:40:55Z","board_verified":true,"closed_at":null,"days_open":95,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":94},"description":"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.\nThe role partners closely with Manufacturing Engineering, Maintenance, Operations, Quality, Validation, Automation, MSAT, EHS, and Project Engineering. It is intentionally focused on eliminating systemic causes-not owning day-to-day equipment setup or serving as the primary coordinator during emergency breakdowns.\nEssential Duties and Responsibilities\nReliability strategy and asset performance\nDevelop and maintainreliability strategies for critical assets based on equipment criticality, failure history, product/process risk, and lifecycle stage.\n\nEstablishasset performance baselines and monitoravailability, reliability, maintainability, downtime, repeat failures, and chronic lossdrivers.\n\nBuild and maintainequipment criticality assessments, bad-actor lists, reliability roadmaps, and risk-ranked improvement backlogs.\n\nSupport asset lifecycle decisions, including repair-versus-replace analyses, obsolescence planning, spare-parts strategy, and capital recommendations.\n\nFailure elimination and root cause analysis\nLead structured RCAs for repeat, high-risk, or high-impact equipment and process failures using appropriate methodssuch as 5-Why, fault-tree analysis, fishbone, FMEA, and data trending.\n\nTranslate event evidence into defensible failure mechanisms, corrective actions, owners, due dates, and measurable effectiveness criteria.\n\nIdentifycommon-cause and systemic issues across assets rather than treating failures as isolated work orders.\n\nProvide technical support to investigations, deviations, CAPAs, audit responses, and quality or safety events involving equipment performance.\n\nDesign, process, and workflow improvement\nServeas designauthority for modifications to existing equipment within delegatedscope, including mechanical, controls, instrumentation, guarding, utility interface, and workflow improvements.\n\nDevelop technical scopes, engineering calculations, drawings, specifications, risk assessments, and acceptance criteria for reliability improvements.\n\nLead process and process-flow optimization when equipment design, system interaction, workflow, or risk controls must change.\n\nEnsure modifications are evaluated and implemented through applicable change-control, validation, commissioning, documentation, and training processes.\n\nConfirm that improvements do not adversely affect validated state, product quality, data integrity, operator safety, cleanroom performance, or regulatory compliance.\n\nMaintenance and condition-based reliability\nOptimizepreventive maintenance tasks and frequencies using failure modes, work-order history, OEM guidance, inspection results, and risk-not calendar frequency alone.\n\nDevelop predictive and condition-monitoring approaches where justified, including vibration, thermography, oil analysis, motor-current analysis, ultrasound, calibration drift, and process-variable trending.\n\nDefine maintenancejob plans, precision-maintenance requirements, lubrication standards, alignment/balancing expectations, and post-maintenance acceptance checks with Maintenance.\n\nEvaluate spare-parts criticality, bills of material, min/max levels, componentstandardization, and obsolescence risk with Maintenance and Supply Chain.\n\nData, metrics, and continuous improvement\nUse CMMS, automation, historian, alarm, batch, quality, and production data to identifytrends and quantify losses.\n\nDevelop Pareto analyses and reliability dashboards that make repeat failures, downtime, maintenance effectiveness, and improvement progress visible.\n\nFacilitatecross-functional improvement efforts using Lean, Six Sigma, and reliability-centered problem-solving principles as appropriate.\n\nDefine benefit assumptions before implementation and verify results after implementation, including recurrence, uptime, quality, safety, labor, scrap, and cost impacts.\n\nCross-functional technical leadership\nPartner with Manufacturing Engineering following breakdowns to determinewhether formal RCA, redesign, maintenance strategy change, or other long-term action is required.\n\nProvide technical direction to Maintenance for implementation of approved reliability improvements and confirm execution meets design intent.\n\nConsult with Project Engineering on reliability, maintainability, accessibility, critical spares, controls, and lifecycle risks for new assets; support transition into steady-state ownership.\n\nCoach engineers, technicians, supervisors, and operators in structured troubleshooting, defect elimination, and reliability fundamentals.\n\nManage vendors and contractors supporting analyses, fabrication, testing, inspection, and improvement implementation within assigned scope.\n\nGxPdocumentation and compliance\nCreate and maintaincomplete, accurate, and audit-ready engineering records in accordance withGDP, data-integrity, and site procedures.\n\nSupport development and revision of SOPs, PMs, engineering standards, drawings, equipment files, and training materials affected by reliability changes.\n\nParticipatein change controls, risk assessments, commissioning/qualification activities, and validationimpact assessments as the engineering subject-matter expert.\n\nPerform all work in accordance withapplicable cGMP, EHS, quality-system, and site requirements.\n\nQualifications\nBachelor’s degree in Mechanical, Electrical, Chemical, Manufacturing, Industrial, Reliability Engineering, or a relatedtechnical discipline.\n\n5 or more years of engineering experience in manufacturing, maintenance, equipment reliability, process engineering, or a relatedfield.\n\nDemonstratedexperience leading RCAs and implementing permanent corrective actions for complex equipment or process failures.\n\nWorking knowledge of preventive/predictive maintenance, equipment criticality, FMEA, lifecycle risk, and reliability metrics.\n\nExperience developing or implementing equipment modifications through a controlled engineering-change process.\n\nAbility to interpret mechanical drawings, P&IDs, electrical schematics, technical manuals, control narratives, and equipment data.\n\nStrong technical writing, data analysis, project execution, facilitation, and cross-functional communication skills.\n\nAbility to work independently, prioritize risk, and influence execution without direct authority over partner functions.\n\nPreferred Qualifications\nExperience in pharmaceutical, biotechnology, medical-device, food, chemical, or anotherhighly regulated manufacturing environment.\n\nKnowledge of cGMP, 21 CFR Parts 210/211, data integrity, change control, deviation/CAPA systems, and commissioning/qualification practices.\n\nExperience with automated manufacturing or packaging equipment, aseptic processing, clean utilities, HVAC/cleanrooms, instrumentation, PLC/HMI systems, or process historians.\n\nExperience using a CMMS/EAM system and analyzing work-order, downtime, alarm, process, and maintenance-cost data.\n\nCMRP, CRE, CRL, Lean Six Sigma, vibration analysis, thermography, or related certification/training.\n\nExperience with AutoCAD, SolidWorks, statistical-analysis tools, or data-visualization platforms.\n\nPhysical and Work Environment Requirements\nRegularly worksin office, manufacturing, mechanical, warehouse, laboratory, and controlled environments and may be requiredto follow gowning and PPE requirements.\n\nMust 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.\n\nMay occasionally lift or move items up to 25 pounds, subject to site safety practices and reasonable accommodation.\n\nMay provide off-hourstechnical support during significant equipment, safety, quality, or compliance events and during planned implementation windows.\n\nTravel is expected to be limited but may be requiredfor vendor visits, FATs, training, or technical 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