2 reliability engineer jobs found

Job Description Position Summary The Sustaining Engineer is responsible for leading cross-functional projects and engineering initiatives that support the continued manufacture, regulatory compliance, and supply of commercialized medical devices. This role serves as a key liaison between Engineering, Quality, Regulatory Affairs, Supply Chain, Manufacturing, and external suppliers to evaluate, implement, and document product, component, material, and packaging changes. The Sustaining Engineer drives timely resolution of technical and supply-related challenges affecting on-market products by developing risk-based solutions, coordinating design and validation activities, and executing change management processes. This position plays a critical role in ensuring continuity of supply, product quality, and compliance with applicable regulatory requirements. Essential Duties and Responsibilities: Sustaining Engineering & Product Lifecycle Management Lead...

Job Summary: The Utilities Engineer plays a critical role in maintaining the reliability and efficiency of our utility systems that support pharmaceutical manufacturing. This includes managing and ensuring the smooth operation of systems such as HVAC, compressed air, chilled water, steam, purified water, electrical, and waste systems. The position is essential for minimizing downtime, meeting regulatory requirements, and maintaining a safe and compliant environment for production. Duties/Responsibilities: Oversee and maintain the operation of all utility systems including HVAC, water systems (pure water, potable water), steam generation, compressed air, and electrical systems in a cGMP environment. Perform preventive maintenance, calibration, and troubleshooting of utilities equipment to ensure operational reliability and compliance with cGMP and safety standards. Collaborate with cross-functional teams (e.g., Production, Quality, Engineering) to ensure utility systems...