Associate Director, Reliability Engineering

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 140,000 - 200,000; Full time

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking an Associate Director of Reliability Engineering to lead the site reliability program across manufacturing, utilities, facilities, laboratories, and packaging operations.

You will partner with Engineering, Manufacturing, Quality, Validation, Facilities, Supply Chain, and EHS to maximize equipment uptime, improve RTS performance, asset health, product quality, and regulatory compliance in a GMP environment.

Responsibilities

• Develop and execute the site's Reliability Engineering strategy aligned with business and operational goals.
• Provide 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.
• Partner with Engineering, Manufacturing, Quality, Validation, Facilities, Supply Chain, and EHS teams to ensure reliable and compliant GMP-regulated systems while supporting business objectives and capital investment strategies.

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.

Responsibilities:

Reliability Strategy & Leadership

• Develop and execute the site's Reliability Engineering strategy aligned with business and operational goals.