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Merck · 1 day ago

Director, Engineering

Lansdale, PA

Full-time

Hybrid

Director/Executive

$170K/yr - $267K/yr

10+ years exp

Merck is a leading pharmaceutical company seeking a highly skilled and strategic Reliability Engineering Director to lead their reliability engineering efforts within the Vaccine manufacturing environment. This role is critical to ensuring the continuous, compliant, and efficient operation of manufacturing equipment and systems that support drug production, involving collaboration with various teams and management of reliability projects.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Lead and develop the reliability engineering team composed of engineers focused on vaccine manufacturing equipment and systems

Develop and implement reliability strategies to maximize equipment uptime, reduce unplanned downtime, and extend asset life while ensuring compliance with FDA, EMA, and other regulatory requirements

Collaborate closely with Quality Assurance, Validation, Manufacturing, Maintenance, and Engineering teams to embed reliability best practices into equipment design, maintenance, qualification, and operation

Facilitate RBAM (reliability based asset management) on key manufacturing assets and utilize/track key reliability metrics such as MTBF (Mean Time Between Failures), MTTR (Mean Time To Repair), and OEE (Overall Equipment Effectiveness) ensuring actions are completed and driving improved performance and risk ranking of assets

Drive root cause analysis and failure investigations for critical equipment, ensuring corrective and preventive actions (CAPA) are implemented effectively

Oversee reliability-centered maintenance (RCM) programs and predictive maintenance initiatives using condition monitoring and data analytics

Ensure all reliability activities comply with Good Manufacturing Practices (GMP) and support audit readiness

Lead risk assessments related to equipment reliability and support validation activities, including IQ/OQ/PQ protocols

Manage budgets, resources, and timelines for reliability projects and continuous improvement initiatives

Communicate reliability goals, progress, and outcomes to senior leadership and cross-functional stakeholders

Qualification

Reliability EngineeringPharmaceutical ManufacturingRegulatory RequirementsLeadershipEnterprise Asset Management (EAM)Reliability Centered Maintenance (RCM)Root Cause AnalysisData AnalyticsChange AgilityCross-Cultural AwarenessInnovationPeople LeadershipLean ManufacturingLean Six SigmaOperations ManagementPortfolio ManagementProgram ManagementGxP ComplianceEngineering DesignFacility ManagementProblem-SolvingCommunicationProject Management