Title: Reliability and Risk Engineer
Location: Remote
Duration: 6+ months with potential for extension.
Job Description:
Our client is seeking an experienced Reliability & Risk Consultant to support a critical initiative focused on improving equipment reliability, risk management, and operational performance within a highly regulated plasma collection and donor screening environment.
This individual will partner closely with engineering, operations, quality, and leadership teams to assess reliability risks, develop risk mitigation strategies, and drive improvements across key performance indicators including MTBF, MTTR, OEE, downtime, and equipment failure rates.
The consultant will be responsible for identifying and evaluating equipment and process risks, maintaining risk registers, establishing risk ranking and criticality methodologies, and helping the organization better quantify operational impact and business risk.
The ideal candidate will bring hands-on experience leading reliability and risk assessments in a regulated manufacturing, medical device, biologics, plasma, or pharmaceutical environment.
Strong knowledge of risk management principles, ISO 14971, CAPA systems, deviations, root cause investigations, and risk mitigation planning is required. Experience utilizing reliability platforms, CMMS, EAM, or asset management systems is highly desirable, though specific software experience is flexible.
This is a highly visible, client-facing role that will require regular interaction with cross-functional stakeholders and senior leadership, including participation in daily and weekly workstream meetings, presentation of findings, and communication of risk-based recommendations to support strategic decision-making