Position Summary:
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.
Key Responsibilities:
Reliability & Asset Management
- 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
SAP EAM & Data Utilization
- 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
Utilities Systems Expertise
- 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
GMP Compliance & Quality Support
- 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
Continuous Improvement
- 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
Required Qualifications
- 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
Preferred Qualifications
- 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
Key Competencies
- 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
