Senior Critical Utilities Engineer Bloomington, Indiana, United StatesSimtra 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. 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:
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance 401(k) Retirement Savings Plan with Company MatchTime Off Program
- Paid Holidays
- Paid Time OffPaid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance ProgramEmployee Assistance Program
- Community and Volunteer Service ProgramEmployee Ownership Plan
Additional Benefits:- Short and Long-Term Disability Insurance
- Voluntary Insurance Benefits
- Vision Coverage
- AccidentCritical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities
- Workout Facility
- CafeteriaCredit Union
Current benefit offerings are in effect through 12/31/26 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.
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.
