Simtra BioPharma Solutions · 16 hours ago
Utilities Engineer II
Simtra BioPharma Solutions is a leading Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies. The Utilities Engineer II is responsible for the continuous improvement and technical support of critical utility systems, ensuring optimal performance and compliance in a GMP environment.
BiopharmaManufacturingMedicalPharmaceutical
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
Qualification
Required
BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) or HS Diploma/GED and 10+ years of relevant experience
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
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
Preferred
Preferable experience in an aseptic production facility
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
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Workout Facility
Cafeteria
Credit Union
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Recent News
2026-01-22
2026-01-20
Company data provided by crunchbase