For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

A Principal 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 reports to the Manager of Critical Utility Maintenance.

What you'll be doing:

• 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 and use, 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
• 5 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
• Working knowledge of industrial refrigeration in a cGMP pharmaceutical environment
• Preferred experience in an aseptic production facility
• 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
• Competency in Reliability Centered Maintenance (RCM)
• Excellent communication skills
• Demonstrated ability to work as part of a multidisciplinary team

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Equal Employment Opportunity

Simtra is 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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Reasonable Accommodations

Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on thelink here and let us know the nature of your request along with your contact information.

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