Associate Director, Reliability Engineering

Simtrabps; Bloomington (IN); On-site; USD 170,000 - 210,000; Full time

Job summary

Simtra BioPharma Solutions is seeking an Associate Director of Reliability Engineering to lead and continuously improve the site reliability program in a GMP manufacturing environment. You will partner with Engineering, Manufacturing, Quality, Validation, Facilities, and EHS to ensure reliable operation of critical systems and regulatory compliance.

The role drives RCM, asset lifecycle, and predictive/ preventive maintenance programs while pursuing continuous improvement in manufacturing,

Qualifications

• Must lead Reliability Engineering programs to maximize uptime and compliance in a GMP environment.
• Experience developing and executing RCM, asset lifecycle, and preventive/predictive maintenance programs.
• Ability to perform RCA, FMEA and risk assessments to improve equipment performance.

Responsibilities

• Develop and execute the site's Reliability Engineering strategy aligned with business goals.
• Improve shutdown programs and RTS performance across facilities.
• Lead reliability initiatives for manufacturing equipment, process systems, utilities, and critical facilities.
• Establish reliability standards, policies, and best practices site-wide.
• Communicate reliability metrics to site leadership as a KPI.
• Serve as SME for asset reliability and maintenance excellence.

Skills

Reliability engineering

RCM

Asset lifecycle management

Predictive maintenance

FMEA

RCA

OEE

cGMP compliance

FDA/EMA regulatory

Leadership

Cross-functional collaboration

Tools

CMMS

Job description

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.

Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

This role:

The Associate Director of Reliability Engineering is responsible for developing, leading, and continuously improving the site reliability program to maximize equipment uptime, shutdown RTS performance, asset performance, product quality, safety, and regulatory compliance within a pharmaceutical manufacturing environment. This role provides strategic leadership for reliability-centered maintenance (RCM), asset lifecycle management, predictive and preventive maintenance programs, and continuous improvement initiatives across manufacturing, utilities, facilities, laboratories, and packaging operations.

The Associate Director partners closely with Engineering, Manufacturing, Quality, Validation, Facilities, Supply Chain, and EHS teams to ensure reliable and compliant operation of GMP-regulated systems while supporting business objectives, production targets, and capital investment strategies.

The responsibilities:

Reliability Strategy & Leadership

• Develop and execute the site's Reliability Engineering strategy aligned with business and operational goals.
• Improve and optimize manufacturing building shutdown program and vertical RTS (return to service) performance.
• Lead reliability improvement initiatives for manufacturing equipment, process systems, utilities, and critical facilities.
• Establish reliability standards, policies, procedures, and best practices across the organization.
• Lead and communication reliability metrics data to site leadership.
• Serve as the subject matter expert for asset reliability and maintenance excellence.

Asset Reliability & Performance Management

• Develop and manage Reliability-Centered Maintenance (RCM) programs.
• Analyze equipment performance, failure trends, and maintenance effectiveness to improve reliability.
• Conduct root cause analysis (RCA), failure mode and effects analysis (FMEA), and risk assessments.
• Identify and implement solutions to reduce downtime and improve Overall Equipment Effectiveness (OEE).
• Establish asset criticality models and reliability KPIs.

Maintenance Excellence

• Partner with Maintenance and Operations teams to optimize preventive and predictive maintenance programs.
• Drive implementation and utilization of condition-based monitoring technologies, including:
  • Vibration analysis
  • Infrared thermography
  • Oil analysis
  • Ultrasound monitoring
  • Motor circuit analysis
• Support maintenance planning, scheduling, and work management processes within CMMS platforms.
• Monitor maintenance performance metrics and identify continuous improvement opportunities.

Pharmaceutical Compliance & Quality

• Ensure reliability programs comply with cGMP, FDA, EMA, and applicable regulatory requirements.
• Support regulatory inspections, audits, and quality investigations.
• Collaborate with Quality Assurance and Validation teams to maintain validated states of equipment and systems.
• Participate in deviation investigations, CAPA development, and change control processes.
• Ensure data integrity, documentation accuracy, and adherence to quality standards.

Utilities, Facilities & Critical Systems

• Provide reliability oversight for critical GMP systems, including:
  • HVAC
  • Water for Injection (WFI)
  • Clean Steam
  • Compressed A