The Reliability Engineer, Utilities is responsible for establishing and driving a data-driven reliability program for critical pharmaceutical utility systems, including WFI, clean steam, HVAC, chilled water, compressed air, and electrical distribution.
This role focuses on improving equipment reliability, reducing repeat failures, and optimizing preventive maintenance strategies while building and utilizing SAP EAM (S/4HANA) as a system of record for asset performance and decision-making.
This is a hands-on role requiring both technical expertise and the ability to implement sustainable improvements in a GMP-regulated manufacturing environment.
Develop and implement reliability strategies for utility assets (e.g., HVAC, chilled water, boilers, WFI, clean steam, compressed air, electrical systems).
Perform RCA, FMEA, and reliability-centered maintenance (RCM) analyses
Analyze equipment performance data, downtime trends, and failure modes
Optimize maintenance strategies to improve uptime and reduce lifecycle cost
Establish and maintain asset criticality and risk-based maintenance plans
Lead improvements in SAP EAM (S/4HANA) to ensure it functions as a reliable source of asset data
Develop and maintain asset hierarchies, maintenance plans, and measuring points
Build and utilize reports and dashboards for:
Backlog and aging
PM effectiveness
Failure trends
Drive adoption and consistent use of SAP workflows across maintenance and engineering teams
Provide technical oversight and reliability support for:
Water systems (WFI, RO/EDI, storage & distribution)
Clean steam systems
HVAC and environmental control systems
Compressed air and process gases
Electrical distribution systems
Analyze and trend critical parameters (e.g., conductivity, TOC, temperature, pressure, flow)
Evaluate system performance relative to product quality and regulatory requirements
Ensure utility systems operate in compliance with FDA, EMA, and GMP requirements
Support deviations, CAPAs, change controls, and investigations related to utilities
Provide technical input for validation activities (IQ/OQ/PQ)
Maintain documentation aligned with SOPs and quality systems
Drive measurable improvements in:
Equipment uptime
PM effectiveness
Reduction of repeat failures
Identify and implement predictive and condition-based maintenance strategies
Support capital projects and equipment upgrades with a reliability-focused approach
Train and mentor maintenance and engineering personnel on reliability best practices
Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related field)
5+ years of experience in reliability, maintenance engineering, or utilities engineering
Hands-on experience with SAP PM / SAP EAM (S/4HANA preferred)
Experience in pharmaceutical or GMP-regulated manufacturing environments
Strong understanding of utility systems, especially water systems (WFI, RO/EDI)
Demonstrated experience with RCA, FMEA, and data-driven problem solving
Experience improving PM programs and maintenance effectiveness
Familiarity with predictive maintenance technologies (vibration, thermography, etc.)
Certified Reliability Engineer (CRE) or similar certification
Experience supporting regulatory inspections and audits
Experience building or improving CMMS data structures and reporting
Strong analytical and problem-solving capability
Ability to translate data into actionable improvements
Effective cross-functional communication
Ownership mindset with ability to drive change
Detail-oriented with strong compliance awareness
Originally posted by Exela Pharma Sciences. View original posting
BioCareerAI is an independent job platform and is not affiliated with or endorsed by Exela Pharma Sciences.