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.
The Role:
A 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 youll 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:
In return youll be eligible for1:
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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IC
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