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 utilities
  
  
  
  

• Financial & Capital Planning
  
  
  
  • Develop and manage department budgets, including operating expenses and capital investments
  • Provide input into the capital plan for utility infrastructure upgrades, replacements, and expansions
  • Evaluate vendor proposals and manage contractor performance for utility-related services
  
  
  
  

Required qualifications:

• BS in Engineering (Mechanical, Electrical, Chemical, or related field required), preferably MS degree in Engineering
• 10+ years of experience in utility engineering and maintenance, with at least 5 years in a leadership role within a regulated pharmaceutical, biotech, or similarly regulated manufacturing environment
• In-depth knowledge of pharmaceutical utility systems, including clean steam, WFI, HVAC, and critical power systems
• Strong understanding of GMP regulations, FDA/EMA guidance, ISPE Baseline Guides, and industry best practices
• Demonstrated expertise in reliability, maintenance management systems, and lifecycle asset management

Physical / Safety Requirements:

• Must be able to lift, push/pull, and carry up to 50 pounds
• May be required to stand for over 4 hours per day
• Must be able to lift 20 pounds overhead
• Must be able to wear personal protective equipment
• Duties may require overtime work, including nights and weekends
• Must be willing to provide phone support 24/7 as needed to support facility activities

In return, you'll be eligible for[1]:

• Day One Benefits
  
  
  
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    
    
    
    • Spouse Life Insurance
    • Child Life Insurance
    
    
    
    
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    
    
    
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
    
    
    
    
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
  
  
  
  
• Additional Benefits
  
  
  
  • Voluntary Insurance Benefits
    
    
    
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
    
    
    
    
  • Onsite Campus Amenities
    
    
    
    • Workout Facility
    • Cafeteria
    • Credit Union
    
    
    
    
  
  
  
  

[1] Current benefit offerings are in effect through 12/31/25

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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