Reliability Engineer

Responsibilities

• Develops and maintains reliability programs, including preventive and predictive maintenance strategies for manufacturing and facility equipment.
• Authors and approves reliability-related documentation, including maintenance plans, equipment lifecycle assessments, and reliability studies.
• Performs root cause analysis (RCA), statistical analysis, and failure mode and effects analysis (FMEA) to reduce equipment downtime and improve system performance.
• Supports investigations, deviations, and CAPAs related to equipment failures, maintenance issues, or reliability events.
• Partners with Engineering, Maintenance, Facilities, Manufacturing, and Quality Assurance to ensure reliability strategies align with site and corporate objectives.
• Implements data-driven improvements for equipment performance, availability, and maintainability.
• Identifies and leads continuous improvement initiatives targeting uptime, cost reduction, and asset optimization.
• Provides subject-matter expertise on reliability engineering methodologies, tools, and industry best practices.
• Ensures all maintenance and reliability programs comply with cGMP guidelines and applicable regulatory requirements.
• Supports the introduction of new equipment, including reliability risk assessments, maintenance planning, spare parts strategies, and training.
• Represents the reliability program during internal and external audits.
• Develops technical reports, maintenance plans, and documentation aligned with corporate engineering and industry standards.
• Evaluates issues from diverse perspectives (safety, compliance, process, equipment, and human factors) to implement durable corrective actions.
• Maintains alignment with internal stakeholders on reliability goals, KPI metrics, and implementation of engineering standards.
• Assists with risk assessments, equipment criticality assessments, and reliability planning activities for new or existing manufacturing systems.
• Assists with facility master planning, including asset lifecycle assessments and asset re-capitalization plan.

Qualifications

• Bachelor’s or Master’s Degree in Engineering (Mechanical, Chemical, Electrical, Industrial), Science, or related field—or equivalent education and experience.
• 4+ years practical experience, with at least 3+ years in reliability engineering, maintenance engineering, or related field.
• Requires in-depth knowledge and experience and the ability to work independently.
• Strong ability to analyze and interpret engineering data, technical documents, and scientific publications.
• Proficient in reliability engineering tools such as RCA, FMEA, Weibull analysis, failure diagnostics, or condition-based monitoring.
• Strong writing and communication skills, with the ability to convey technical information to cross-functional audiences.
• Working knowledge of pharmaceutical manufacturing processes, reliability best practices, and quality system requirements.
• Experience with maintenance management systems (e.g., CMMS), reliability software, or statistical tools preferred.
• Ability to manage multiple priorities, meet deadlines, and balance long-term reliability initiatives with immediate operational needs.
• Knowledge of cGMP guidelines and international regulations related to API or drug product manufacturing.
• Demonstrated technical competence and ongoing engagement in the field of reliability engineering.