Excel Engineering · 1 day ago
Reliability Engineer (KY)
Lexington, KY
Full-time
Onsite
Senior Level
5+ years expExcel Engineering is seeking a team-oriented, highly motivated hands-on Reliability Engineer to elevate equipment performance and asset integrity across a cGMP pharmaceutical production environment. The role involves assessing criticality analysis, preventive & predictive strategies, root-cause investigations, and continuous improvement to safeguard product quality, throughput, and compliance.
Industrial AutomationIndustrial EngineeringProject Management
Responsibilities
Build and maintain asset hierarchies; perform equipment criticality analysis, FMEA, and develop risk-based PM/PdM plans
Deploy and interpret condition monitoring (vibration, infrared/thermography, ultrasonic, oil analysis) to anticipate failures and optimize maintenance intervals
Configure and improve workflows in CMMS (e.g., SAP PM/Maximo) for work orders, BOMs, spare parts, and maintenance KPIs; drive data accuracy and 21 CFR Part 11-aligned record integrity
Facilitate structured Root Cause Analysis (5-Whys, Ishikawa) and author CAPA plans that are compliant, effective, and auditable; track effectiveness checks
Own reliability strategies for sterile utilities and process systems (e.g., WFI, clean steam, HVAC/HEPA, compressed air, autoclaves, reactors, etc)
Plan maintenance windows/turnarounds; collaborate via formal change control for reliability-driven modifications; support validation/qualification impacts (IQ/OQ/PQ readiness)
Set stocking strategies for critical spares; evaluate lifecycle costs, MTBF/MTTR, and repair/replace decisions; manage vendor performance
Define and publish metrics (OEE, PM compliance, maintenance backlog, failure rates, cost per asset); run daily/weekly tier meetings and lead continuous improvement sprints
Partner with Operations, Quality, Validation, EHS, and Engineering; train technicians on reliability standards and PdM tools; support audit responses (FDA/EMA)
Qualification
Required
Bachelors or Masters' Degree in Chemical, Mechanical or Electrical Engineering from an ABET Accredited Institution
Cumulative GPA of 3.0 or higher on a 4.0 Scale
5–10+ years in reliability/maintenance within industrial manufacturing sector; Preferred experience in cGMP environment
Proficiency in CMMS (SAP PM, Maximo or similar), PdM technologies, failure analysis methodologies (FMEA, Weibull), and maintenance planning/scheduling
Strong facilitation and communication skills; ability to influence cross-functional teams; crisp technical writing for investigations and protocols
Excellent interpersonal skills, as well as verbal and written communications
Ability to work collaboratively with individuals at all levels in the organization in a team environment
Knowledge of relevant technical software
Knowledge of MS Office software products: Word/Excel/Outlook
Preferred
CMRP/CRE certifications
pharmaceutical utilities experience (WFI, clean steam)
aseptic/sterile manufacturing exposure
TPM/Lean background
Benefits
Competitive salary and benefits package
Company
Excel Engineering
Excel Engineering is an automation company that focuses on electrical, transmission, and IT/OT system engineering services.
51-200 employees
H1B Sponsorship
Excel Engineering has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
MICHAEL "RANGER" WILLIAMS
TRANSMISSION LINE INSPECTOR
Recent News
Seattle TechFlash
2025-04-03
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