Reliability Engineer

• Assess and monitor manufacturing equipment to ensure reliable operation.
• Develop, implement, and optimize preventive and predictive maintenance programs.
• Identify recurring equipment failures and implement long-term corrective solutions.
• Analyze equipment performance and recommend improvements to increase uptime.
• Ensure appropriate critical spare parts are available.
• Partner with Maintenance to improve equipment availability and operational efficiency.
• Track production losses, equipment downtime, and high-maintenance-cost assets.
• Analyze equipment and maintenance data to identify failure trends.
• Develop and monitor key reliability metrics, including:
• Mean Time to Failure (MTTF)
• Mean Time to Repair (MTTR)
• Total Cost of Ownership (TCO)
• Life Cycle Cost (LCC)
• Identify opportunities to reduce maintenance spending and production losses.
• Utilize data analysis and statistical tools to drive improvement decisions.
• Lead process and equipment improvement projects from design through implementation.
• Develop solutions to improve equipment reliability and operational performance.
• Coordinate project activities with Engineering, Maintenance, Production, and other departments.
• Manage multiple improvement initiatives simultaneously.
• Support equipment life-cycle planning and long-term asset performance.
• Ensure engineering and maintenance activities comply with applicable GMP manufacturing requirements.
• Initiate and execute change controls associated with equipment and process improvements.
• Revise Standard Work Instructions (SWIs) and related documentation.
• Coordinate implementation of equipment modifications and close out change controls.
• Participate in equipment and process qualification and validation.
• Support regulatory compliance, safety initiatives, and risk mitigation.
• Collaborate with Quality and other departments to maintain compliant manufacturing operations.

• Bachelor’s degree in Mechanical Engineering.
• Minimum 5 years of relevant engineering experience in manufacturing, equipment reliability, maintenance engineering, or a closely related field.
• Prior experience working in a GMP-regulated manufacturing environment is required.
• Experience with equipment reliability, preventive maintenance, and manufacturing equipment troubleshooting.
• Ability to analyze equipment performance and identify opportunities to reduce downtime.
• Understanding of maintenance and reliability metrics.
• Experience working with computerized maintenance management systems (CMMS).
• Knowledge of manufacturing regulatory requirements and engineering change controls.
• Strong project management and cross-functional communication skills.
• Important Client Clarification: GMP manufacturing experience is required. Chemical or pharmaceutical manufacturing experience is highly preferred but is not strictly required if the candidate has transferable GMP manufacturing experience.

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.