Reliability Engineer_SUB-HEM-004 at Software Galaxy Systems, LLC

Job Description:

• Pharma cGMP experience preferred.
• 5+ years of experience.
• Onsite position, *Must be able to travel to all 4 Client’s sites in Tampa, primarily working between the Manufacturing and Packaging buildings.
• Looking for candidates with more Reliability background instead of Validation experience.
• Reliability engineering and improving equipment uptime.

Summary:

• The Reliability Engineer (contingent) is responsible for the review of equipment and systems to determine appropriate maintenance strategies to maintain equipment integrity.
• The Reliability Engineer reviews equipment manuals, equipment installations, qualifications, and proposed maintenance plans for accuracy, efficiency, detail, and applicability.
• May develop Failure Mode and Effect Assessments and / or contact manufacturers to ensure completeness of maintenance plans and spare part assessments. Identifies and recommends spare parts for equipment and equipment systems based on criticality and failure potential.

Key Accountabilities:

• Develops maintenance plans and procedures to be used by internal staff and external contractors to troubleshoot, repair, maintain, calibrate, and test equipment and components for systems such as: Solid Dose Manufacturing (SDM) Production and Packaging equipment, Utility supplies (water, gas, electrical), HVAC, chillers, air compressors, water purification systems, boilers, air handling units, ISO classified clean rooms, and exhaust equipment.
• Evaluates equipment and systems for measures to improve reliability and integrity including the performance of failure analysis as necessary. Develops, as applicable, an equipment replacement schedule based on life expectancy, operational history, criticality, and age.
• Write, review, update, and approve User Requirement Specifications, Functional Specifications, Design Specifications, Operation and Maintenance Manuals, Standard Operating Procedures (SOPs) for the new and existing systems as required.
• Assist in equipment failure analysis, root cause determination, and propose corrective and preventative (CAPA) measures.
• Comply with all state and federal regulatory requirements and guidelines applicable to performance of maintenance needs.