Utilities Engineer I

STAQ Pharma Inc•Columbus, OH

11d

About The Position

The Utilities Engineer plays a critical role in maintaining the reliability and efficiency of our utility systems that support pharmaceutical manufacturing. This includes managing and ensuring the smooth operation of systems such as HVAC, compressed air, chilled water, steam, purified water, electrical, and waste systems. The position is essential for minimizing downtime, meeting regulatory requirements, and maintaining a safe and compliant environment for production.

Requirements

Must be a team player and effectively collaborate with internal departments.
Excellent attention to detail.
Experience in a regulated manufacturing industry.
Demonstrates ability to handle multiple responsibilities at any given time.
Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field
Minimum of 1+ years of experience in engineering within the pharmaceutical or biotech industry.
Strong knowledge of cGMP regulations and FDA guidelines
Excellent oral communication and technical writing skills.
Microsoft word and excel experience.
Experience with utility systems such as HVAC, Sterile water for Injection Generation. water treatment, steam generation, compressed air, and electrical systems.
Familiarity with environmental and safety regulations and the ability to implement safety best practices.

Nice To Haves

Experience with Lean Manufacturing and Six Sigma methodologies is a plus
AutoCAD, asset management systems, cGMP change management software experience preferred.

Responsibilities

Oversee and maintain the operation of all utility systems including HVAC, water systems (pure water, potable water), steam generation, compressed air, and electrical systems in a cGMP environment.
Perform preventive maintenance, calibration, and troubleshooting of utilities equipment to ensure operational reliability and compliance with cGMP and safety standards.
Collaborate with cross-functional teams (e.g., Production, Quality, Engineering) to ensure utility systems support manufacturing activities without disruption.
Participate in the design, installation, and commissioning of new utility systems, ensuring they are in compliance with regulatory requirements and industry best practices.
Monitor utility performance and recommend improvements to increase efficiency, reduce costs, and minimize downtime.
Maintain up-to-date documentation for all utility systems, including SOPs, work instructions, and equipment logs.
Ensure that all systems are in compliance with environmental, health, and safety regulations.
Provide technical support and troubleshooting assistance for critical utility-related issues during production.
Support continuous improvement initiatives and help implement energy-saving programs.
Lead or support investigations related to utility failures, non-conformances, or deviations in the manufacturing process.
Support MSAT daily operations including Asset Management, Validation, Design/Drafting, and Project Management.
Monitor the facility monitoring system and building automation systems to ensure optimal environmental conditions and compliance with regulatory requirements.
Work with production operators, maintenance technicians and vendors staff on solving technical problems