Utilities Engineer
Simtra BioPharma Solutions
About the role
About
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?
- 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.
Role Overview
A Utilities Engineer is responsible for continuous improvement, technical support and troubleshooting as required on critical utility systems. This role will manage maintenance programs for all existing critical utilities (preventive, reactive, corrective and predictive) and improvement projects, including vendor relations, procurement, installation, and functional testing to achieve both budget and timeline requirements. The position is 100 % onsite at the Bloomington facility and reports to the Manager of Process Engineering.
Responsibilities
- Support in the design and maintenance of utilities and associated systems, including cooling towers, compressed air generation and distribution, chilled water generation and distribution, air handling units (AHUs) supporting aseptic processing, electrical distribution and backup systems, boiler/steam generation and distribution, clean steam generation, fire suppression, and water for injection (WFI) production and distribution to points of use.
- Monitor and troubleshoot utilities systems and associated equipment to identify and resolve issues promptly, minimizing downtime.
- Provide active supervision of technical building systems in the GMP environment, including electricity/emergency power, refrigeration, cooling and vacuum technology.
- Plan and implement activities during shutdowns, new installations, and process optimization of utilities systems.
- Create cGMP/GDP‑compliant lifecycle documentation, maintenance and qualification procedures, and operating instructions, including change controls as necessary.
- Serve as subject matter expert for building monitoring and work order systems.
- Drive 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 execute 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.
- Lead continuous improvement initiatives to enhance efficiency, reliability, and sustainability of utilities systems and equipment.
- Prepare and maintain documentation, including standard operating procedures, equipment manuals, and maintenance records.
- Utilize root cause analysis techniques to investigate process and equipment issues and implement sustainable preventative actions.
- Own the qualified state of the critical utilities equipment.
What You’ll Bring (Requirements)
- BS degree in Engineering or Technology (required).
- 3+ years’ experience in the 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 50 lb.
- Must be able to gown qualify for Grade A/B area.
- Position requires sitting or standing for long hours.
Benefits
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance (including supplemental, spouse, and child coverage)
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program, Paid Holidays, Paid Time Off, Paid Parental Leave, Adoption Reimbursement Program
- Education Assistance Program, Employee Assistance Program, Community and Volunteer Service Program, Employee Ownership Plan
- Short and Long‑Term Disability Insurance, Voluntary Insurance Benefits, Vision Coverage, Accident, Critical Illness, Hospital Indemnity Insurance, Identity Theft Protection, Legal assistance, and more
- Onsite Campus Amenities: Workout Facility, Cafeteria, Credit Union
Current benefit offerings are in effect through 12/31/26.
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.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
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