Director of Reliability Engineering

A company is looking for a Director of Reliability Engineering & Asset Management in a BioPharma environment.

Key Responsibilities

Lead and oversee a team of subject matter experts in Reliability Engineering & Asset Management operations and strategic initiatives

Ensure compliance with FDA regulations and cGMP standards while promoting a culture of safety and operational excellence

Analyze maintenance data, develop KPIs and SLAs, and act as the primary liaison during inspections and audits

Required Qualifications

Bachelor's degree in Chemical, Mechanical, Electrical, or Biomedical Engineering; Master's preferred

Minimum 10 years of experience in pharmaceutical / biotech engineering, with 5+ years in a leadership role

Strong command of FDA regulations, cGMP, and other relevant compliance standards

Certified Maintenance & Reliability Professional (CMRP) and CRL certification

Experience with CMMS and preventive maintenance systems