Head of Reliability Engineering, GMP Pharma

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) with Company Match

Paid Holidays

Paid Time Off

Life and AD&D Insurance

Disability Insurance

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks an Associate Director of Reliability Engineering to lead the site reliability program, maximize equipment uptime and regulatory compliance across GMP operations.

You will partner with Engineering, Manufacturing, Quality, Validation and Facilities to implement RCM, predictive maintenance, and continuous improvement initiatives that strengthen asset lifecycle management and production targets.

Qualifications

• Bachelor’s degree in Engineering required.
• Master’s degree in Engineering, Business Administration, or related field preferred.
• 10+ years of engineering, maintenance, or reliability experience in pharmaceutical/manufacturing.
• 5+ years of leadership experience managing technical teams.
• Experience supporting FDA/EMA regulatory inspections and GMP environments.

Responsibilities

• Develop and execute the site Reliability Engineering strategy aligned with goals.
• Improve shutdown and RTS performance for manufacturing facilities.
• Lead reliability improvements for equipment, process systems, utilities and critical facilities.
• Establish reliability standards, policies, and best practices across the organization.
• Lead reliability metrics reporting to site leadership and stakeholders.
• Manage Reliability-Centered Maintenance (RCM) programs and RCA/FMEA activities.
• Reduce downtime and improve Overall Equipment Effectiveness (OEE).
• Ensure compliance with cGMP, FDA/EMA and regulatory requirements; support inspections.
• Oversee critical utilities (HVAC, WFI, Clean Steam, etc.) and facilities reliability.
• Support design reviews and lifecycle management for capital projects.
• Utilize data analytics to drive continuous improvement and Lean/Six Sigma initiatives.

Skills

Leadership

Strategic thinking

Communication

Problem solving

Team management

Education

Bachelor's degree in Engineering

Master's degree in Engineering/Business or related field

Tools

Maximo CMMS

D365

Blue Mountain CMMS

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks an Associate Director of Reliability Engineering to lead the site reliability program, maximize equipment uptime and regulatory compliance across GMP operations.

You will partner with Engineering, Manufacturing, Quality, Validation and Facilities to implement RCM, predictive maintenance, and continuous improvement initiatives that strengthen asset lifecycle management and production targets.