Associate Director – Reliability

The Associate Director – Reliability provides leadership and direction to the reliability organization supporting Houston API manufacturing, ensuring reliability deliverables are sufficiently resourced and qualified to support Small Molecule and Oligonucleotide production goals and the site business agenda. The role holder is directly responsible for the reliability technical programs, the maintenance strategy executed by the maintenance organization, and the analysis of equipment performance that drives its improvement.

Responsibilities

• Lead, supervise, and coach the maintenance organization, including maintenance supervisors, planner/schedulers, craft staff, and contract resources, completing performance management and development planning and ensuring staff are qualified, trained, and authorized to perform their assigned work.
• Own reliability staffing, including recruitment, resource planning, capability development, and succession planning, and build the organization, systems, and business processes required to support GMP operations.
• Develop and maintain the reliability technical programs, including the reliability roadmap, equipment criticality ranking, asset qualification monitoring, and the preventive and predictive maintenance strategy.
• Analyze equipment performance, work order history, failure coding, and downtime data to identify chronic and high-impact failures, applying RCM, FMEA, and RCA to eliminate them.
• Lead the site asset performance review forum, bringing maintenance, operations, and engineering together to review reliability performance and prioritize improvement initiatives.
• Own the Process Safety Management (PSM) program within the engineering scope, including the mechanical integrity strategy for covered equipment, resource assignment, metrics, and audit and action closure.
• Provide oversight of reliability related issues and improvement initiatives, review and approve relevant deviations and change controls affecting equipment reliability and qualified state.
• Set and reinforce reliability standards in partnership with the engineering function and the Engineering Tech Center, ensuring compliance with corporate reliability performance expectations.
• Identify, track, and report key indicators of reliability performance, support site governance, and represent reliability in site expense, capital, and resource planning processes.

Basic Qualifications

• Bachelor’s degree in Engineering.
• 7+ years of experience in engineering, maintenance and/or reliability in a manufacturing environment.
• 3+ years of management or people leadership experience.

Additional Skills/Preferences

• Previous experience in reliability engineering leadership at an FDA regulated, GMP, and Process Safety Management covered manufacturing site.
• Previous experience with active pharmaceutical ingredient manufacturing, including small molecule or oligonucleotide unit operations.
• Proficient in reliability analysis methods including Reliability Centered Maintenance, Failure Mode and Effects Analysis, Root Cause Analysis, and failure distribution analysis.
• Prior work with predictive maintenance technologies such as vibration analysis, thermography, oil analysis, and motor circuit testing, and with mechanical integrity programs for Process Safety Management covered equipment.
• Proficient in computerized maintenance management systems such as SAP or Maximo.
• Proven ability to build and sustain a team culture focused on a Safety First, Quality Always mindset, and to train, mentor, and develop engineers.
• Proven ability to make independent decisions and influence diverse groups across functions.