Sr. Utilities Engineering and Maintenance Manager

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 Senior Utility Engineering Manager is responsible for leading the utility engineering and utility maintenance organizations to ensure reliable, compliant, and efficient operation of all site utilities that support pharmaceutical manufacturing. This role provides technical and managerial leadership to maintain state-of-the-art utility systems, ensure compliance with GMP and regulatory requirements, and deliver a proactive lifecycle approach for utility assets.  The position serves as the primary owner of the utility strategy, aligning capital investment, maintenance programs, engineering projects, and sustainability initiatives to support business objectives and regulatory compliance.  This position reports to the Director, Engineering & Maintenance, and it is onsite 100% at the Bloomington, Indiana facility.

 

The responsibilities:

• Leadership & Strategy
  • Lead, mentor, and develop a cross-functional team of utility engineers and utility maintenance professionals
  • Establish long-term strategy for site utilities, ensuring alignment with business needs, corporate standards, and regulatory requirements
  • Drive a culture of reliability, safety, and compliance across all utility systems and activities
  • Partner with operations, quality, capital projects, and EHS to align priorities and deliver sustainable solutions

• Utility Engineering
  • Oversee design, specification, qualification, and lifecycle management of all critical and non-critical utility systems (e.g., clean utilities, HVAC, water systems, steam, compressed air, electrical, chilled water, plant utilities)
  • Ensure utility engineering team provides robust technical support for capital projects, capacity expansions, and new equipment introductions
  • Implement risk-based approaches to asset management, including FMEA, reliability-centered maintenance (RCM), and state-of-good-repair assessments
  • Lead utility system improvement projects focused on reliability, sustainability, and cost optimization

• Utility Maintenance
  • Ensure effective execution of preventive, predictive, and corrective maintenance programs for all utility assets
  • Oversee work planning, scheduling, and prioritization of maintenance activities
  • Ensure timely resolution of equipment downtime and support root cause investigations
  • Implement best practices in maintenance execution, spare parts management, and CMMS utilization

• Compliance & Quality
  • Ensure all utility operations and documentation comply with cGMP, FDA, EMA, and other global regulatory standards
  • Partner with Quality to support audits, inspections, and deviation/investigation resolution
  • Maintain current knowledge of regulatory expectations and industry standards related to utilitie