Senior Critical Utilities Engineer

Simtrabps; Bloomington (IN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

Flexible

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Critical Utilities Engineer for 100% on-site work. You will maintain and improve critical utilities systems, lead preventive maintenance, and manage vendor relations and projects to meet budget and timelines.

You will drive continuous improvement, ensure GMP compliance, and mentor junior engineers within the Process Engineering team. A BS in engineering and 3+ years in pharma are required.

Qualifications

• 3+ years of experience in a pharmaceutical or highly regulated setting.
• Working knowledge of high and low voltage electrical switchgear and distribution systems.
• Experience with generation, operation, and use of clean steam and WFI generation systems.
• Understanding of controls, wiring and circuitry.
• Experience with hydraulics & pneumatics and operation of air handling systems.
• Experience with automation and programmable logic control (PLC) systems.

Responsibilities

• Support design and maintenance of utilities and related systems (cooling towers, AHUs, electrical distribution, boiler/steam, WFI, water systems).
• Monitor and troubleshoot utilities to minimize downtime.
• Supervise technical building systems in GMP environments (electricity, refrigeration, cooling, vacuum).
• Plan and implement shutdowns, new installations, and process optimization of utilities.
• Create cGMP/GDP lifecycle docs, maintenance, qualification procedures, and change controls as needed.
• Be subject matter expert for building monitoring and work order systems.
• Drive LEAN-based continuous improvement in facilities and processes.
• Collaborate with cross-functional teams for effective integration into manufacturing.
• Develop and execute preventative maintenance plans for utilities and equipment.
• Stay current with regulations and best practices for safety and quality.
• Provide guidance to junior engineers and technicians.

Skills

Pharma industry experience

Electrical distribution knowledge

Project management tools

Clean steam & WFI

Controls & wiring

Hydraulics & pneumatics

PLC systems

Education

BS degree in Engineering or Technology

Tools

LEAN methodologies

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:

A Critical Utilities Engineer is responsible for continuous improvement, technical support and troubleshooting as required on critical utility systems. This role will be responsible for maintenance programs for all existing critical utilities (preventive, reactive, corrective and predictive) and improvement projects, including managing vendor relations, procurement, installation, and functional testing to achieve both budget and timeline requirements. This position is 100% onsite at the Bloomington facility and reports to the Manager of Process Engineering.

The Responsibilities:

• Support in the design and maintenance of utilities and associated systems - including, but not limited to, cooling towers, compressed air generation and distribution systems, chilled water generation and distribution systems, air handling units (AHUs) supporting aseptic processing operations, electrical distribution and backup systems, boiler/steam generation and distribution systems, clean steam generation, fire suppression, water for injection (WFI) production and distribution to points of use
• Monitor and troubleshoot utilities systems and associated equipment to identify and resolve any issues promptly to minimize downtime
• Responsible for and active supervision of technical building systems in the GMP environment, including electricity/emergency power, refrigeration, cooling and vacuum technology
• Detailed planning and implementation during shutdowns, new installations, and process optimization of utilities systems
• Create cGMP/GDP-compliant lifecycle documentation, maintenance, qualifications procedures and operating instructions, including change controls as necessary
• Subject matter expert for building monitoring and work order systems
• Continuous improvement of facilities and processes using LEAN tools and methodologies
• Collaborate with cross-functional teams to ensure utilities systems are integrated effectively into manufacturing processes
• Develop and execution of preventative maintenance plans for utilities systems and associated equipment to ensure optimal performance and compliance
• Stay current with industry regulations and best practices, ensuring utilities systems meet all safety and quality standards
• Provide technical expertise and guidance to junior engineers and technicians within the teams
• Drive continuous improvement initiatives to enhance the efficiency, reliability, and sustainability of utilities systems and associated equipment
• Preparation and maintenance of documentation, including standard operating procedures, equipment manuals, and maintenance records
• Utilize root cause analysis techniques to investigate process and equipment issues and sustainable and preventatives actions
• Own the qualified state of the critical utilities equipment

What you'll bring:

• BS degree in Engineering or Technology required
• 3+ years’ experience in a pharmaceutical industry or in a highly regulated role
• Working knowledge of high and low voltage electrical switchgear and distribution systems
• Working knowledge of common project management tools
• Experience with generation, operation, and use of clean steam and WFI generation systems
• Understanding of controls, wiring and circuitry
• Experience with hydraulics & pneumatics, and operation of air handling systems
• Experience with automation and programmable logic control (PLC) systems

Physical / safety requirements:

• Ability to wear required personal protective equipment (PPE)
• Ability to work overtime, nights, and weekends as business needs require
• Must be able to lift up to 50lbs
• Must be able to gown qualify for Grade A/B area
• Position requires sitting or standing for long hours.

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

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible