Director, Reliability Engineering

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.

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.

The 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 Director of Reliability Engineering 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

• •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.

• •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.

• •Partner with Maintenance and Operations teams to optimize preventive and predictive maintenance programs.
• •Drive implementation and utilization of condition-based monitoring technologies, including:

o Vibration analysis

o Infrared thermography

o Oil analysis

o Ultrasound monitoring

o Motor circuit analysis

• •Support maintenance planning, scheduling, and work management processes within CMMS platforms.
• •Monitor maintenance performance metrics and identify continuous improvement opportunities.

• •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.

• •Provide reliability oversight for critical GMP systems, including:

o HVAC

o Water for Injection (WFI)

o Clean Steam

o Compressed Air

o Building Management Systems (BMS)

• •Support risk mitigation strategies for critical utility and facility assets.
• •Lead initiatives to improve system availability and energy efficiency.

• •Support design reviews and reliability

• •Utilize reliability and maintenance data to drive decision-making.
• •Develop dashboards and reports to monitor reliability performance.
• •Lead Lean, Six Sigma, and operational excellence initiatives.
• •Benchmark reliability performance against industry best practices.
• •Drive digital transformation initiatives related to smart maintenance and Industry 4.0 technologies.

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