Simtra US LLC
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.
This role: A Senior 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 Critical Utility Maintenance.
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 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
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
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
In return, you'll be eligible for [1] :
Day One Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
Short and Long-Term Disability Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program
Paid Holidays
Paid Time Off
Paid Parental Leave and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Additional Benefits
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Onsite Campus Amenities
Workout Facility
Cafeteria
Credit Union
[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.
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/
#J-18808-Ljbffr
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.
This role: A Senior 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 Critical Utility Maintenance.
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 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
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
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
In return, you'll be eligible for [1] :
Day One Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
Short and Long-Term Disability Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program
Paid Holidays
Paid Time Off
Paid Parental Leave and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Additional Benefits
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Onsite Campus Amenities
Workout Facility
Cafeteria
Credit Union
[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.
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/
#J-18808-Ljbffr