Director of Reliability Engineering — GMP Asset Excellence

Simtra BioPharma Solutions; Bloomington (IN); Sur place; USD 180 000 - 210 000; Plein temps

Avantages offerts par ce poste

Medical & Dental Coverage

401(k) Matching

Paid Holidays & PTO

Education Assistance

Employee Ownership Plan

Résumé du poste

Simtra BioPharma Solutions is seeking a Director of Reliability Engineering to lead the site reliability program, maximize equipment uptime, and assure GMP-compliant operations across manufacturing, utilities, facilities, laboratories, and packaging. You will partner with Engineering, Quality, Validation, Facilities, Supply Chain, and EHS to drive reliability initiatives and capital investments.

The role requires 10+ years in pharmaceutical reliability with 5+ years of leadership, strong

Qualifications

• Bachelor's degree in Engineering required; Master's preferred.
• 10+ years in engineering, maintenance, or reliability in regulated manufacturing.
• Experience leading technical teams and implementing reliability programs in GMP environments.

Responsabilités

• Develop and execute the site's Reliability Engineering strategy.
• Lead RCMS programs and improve asset reliability and OEE.
• Drive preventive/predictive maintenance and condition monitoring initiatives.
• Ensure cGMP, FDA/EMA compliance and support audits/inspections.
• Oversee critical GMP systems (HVAC, WFI, Clean Steam, utilities).
• Develop asset lifecycle strategies and participate in capital projects.

Connaissances

Leadership

Strategic thinking

Problem solving

Data analysis

Formation

Bachelor's degree in Engineering

Master's degree in Engineering or MBA

Outils

CMMS (Maximo, D365, Blue Mountain)

Description du poste

Simtra BioPharma Solutions is seeking a Director of Reliability Engineering to lead the site reliability program, maximize equipment uptime, and assure GMP-compliant operations across manufacturing, utilities, facilities, laboratories, and packaging. You will partner with Engineering, Quality, Validation, Facilities, Supply Chain, and EHS to drive reliability initiatives and capital investments.

The role requires 10+ years in pharmaceutical reliability with 5+ years of leadership, strong