Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Various outside weather conditions, Warehouse
Job Description
DESCRIPTION:
The Reliability Engineer is a Subject Matter Expert (SME) responsible for maximizing the operational availability, compliance, and lifecycle health of critical site-wide utility systems, infrastructure, and core pharmaceutical process equipment across a multi-product manufacturing campus. This position will focus heavily on managing risk for critical utility assets (e.g., HVAC, clean steam, and life safety systems) while actively supporting sterile and commercial manufacturing spaces in operational states.
The ideal candidate will utilize data-driven reliability analysis, Root Cause Analysis (RCA), and Reliability Centered Maintenance (RCM) principles to minimize unplanned downtime, prevent regulatory deviations, and optimize maintenance strategies.
REQUIREMENTS:
Utilities, Facilities, Process & Project Support
PM/PdM Optimization: Develop and execute cost-effective preventive (PM) and predictive maintenance (PdM) programs for equipment, life safety, and infrastructure assets.
Failure Analysis: Lead & assist root cause investigations (RCA) and failure mode effects analyses (FMEA) to eliminate chronic equipment failures and downtime.
Lifecycle Metrics: Track equipment uptime, PM completion rates, and conduct asset health assessments for capital expenditure (CAPEX) planning.
Standardization: Standardize common systems and parts to streamline maintenance and reduce facility risk.
Asset Health & Risk: Conducts health assessments on critical assets to determine risks and lifecycle status of the equipment.
System Standardization: Drive initiatives to standardize systems and parts for common systems.
Equipment Onboarding: In-process new capital equipment, establishing maintenance strategies, spare parts inventories, and calibration coordination.
Production Support: Support OSD manufacturing spaces and cutting-edge process equipment without disrupting live production.
Commissioning: Assist with startup, commissioning, qualification and requalification of new and existing plant assets.
Spare Parts Optimization: Derives spare parts strategies for systems based on assessments taking into account impact, availability and cost.
Regulatory, Metrics & Team Collaboration
Compliance: Ensure all work adheres to 21 CFR cGMP regulations, site SOPs, and safety codes.
Documentation: Author SOPs, job plans, and maintenance logs to preserve equipment histories.
Cross-Functional Partner: Coordinate seamlessly with Production, Quality, Validation, Maintenance, and external contractors.
Team Training: When required, may support training operators, technicians and maintenance staff on techniques for managing equipment to improve reliability/uptime.
KPI Tracking: Support development of key metrics and tracking adherence to targets including PM completion rates, Equipment uptime %, Equipment related PRs, Work order submissions and closures by system.
Scope Flexibility: Other tasks that may fall under the umbrella of reliability engineering.
Requirements
Education & Experience
BS in Engineering required (Mechanical, Electrical, Chemical, Bio) + 3-5 years of reliability/maintenance experience. (OR)
AS Technical Degree + 5-6 years of manufacturing maintenance experience
Skills & Qualifications
Preferred: ASQ Certified Reliability Engineer (CRE), SAP proficiency, and pharma/GMP environment experience.
Core Skills: Strong electro-mechanical knowledge, data-driven decision-making, and excellent cross-functional communication.
