Utilities Engineer II

Position Summary:

We are seeking a motivated Engineer II to support the maintenance, optimization, and compliance of critical utility systems at our biopharmaceutical manufacturing and development facility. In this role, you will work closely with a team to ensure the reliability and operational excellence of key systems such as Water for Injection (WFI), Purified Water (PW), HVAC, Building Automation Systems (BAS), Clean-In-Place (CIP), Autoclaves, Glasswash/Clean-Out-Of-Place (COP), Boilers, Process Gases, and Process Chillers. You will contribute to the effective operation of these systems, ensuring they meet all regulatory requirements and operational standards.

Responsibilities:

• Utility Systems Support:
• Lead in the maintenance, troubleshooting, and optimization of essential utility systems, including:
• WFI & PW systems
• HVAC systems
• BAS
• CIP systems
• Autoclaves
• Glasswash/COP
• Steam Generators
• Process Gases (e.g., nitrogen, oxygen)
• Process Chillers
  
  
• Deviation Investigations:
• Lead investigations of deviations in utility systems, assist in identifying root causes, and contribute to the implementation of corrective and preventive actions (CAPA) using the Quality Management System (QMS).
• Change Management:
• Manage engineering changes related to utility systems, ensuring compliance with Change Control procedures. Help implement changes in a timely and effective manner while minimizing operational disruption.
• System Performance Monitoring:
• Monitor the performance of utility systems and help with preventive maintenance schedules, performance reviews, and reliability improvements.
• Regulatory Compliance:
• Work with the engineering team to ensure compliance with cGMP regulations, health, safety, and environmental standards. Help with the creation and maintenance of Standard Operating Procedures (SOPs) for equipment operations.
• Cross-Functional Collaboration:
• Collaborate with internal teams (operations, quality assurance, validation, utilities) to support the integration and troubleshooting of equipment and systems.
• Documentation and Reporting:
• Maintain accurate records of engineering activities, including investigations, corrective actions, equipment maintenance, and changes to systems. Ensure all documentation is compliant with cGMP requirements and audit-ready.
  
  
  

Requirements:

• Education:
• Bachelor’s degree in Engineering, Biotechnology, Biochemical Engineering, or a related field.
• Experience:
• 2 years of engineering experience in a biopharmaceutical manufacturing or regulated environment, with exposure to critical utility systems.
• Technical Skills:
• Knowledge of biopharmaceutical manufacturing processes, equipment, and cGMP regulations.
• Understanding of HVAC, WFI & PW systems, CIP, BAS, autoclaves, boilers, and other utility systems used in biopharmaceutical manufacturing.
• Familiarity with process automation or control systems is a plus.
• Proficiency with engineering software (e.g., AutoCAD, Microsoft Office Suite).
• Problem-Solving and Analytical Skills:
• Strong troubleshooting skills with the ability to assist in root cause analysis and corrective action development.
• Communication Skills:
• Good verbal and written communication skills, with the ability to work effectively with cross-functional teams and external suppliers/contractors.
• Attention to Detail:
• A detail-oriented approach to documentation and compliance, ensuring high standards of equipment management.
  
  
  

Physical Demands & Working Conditions:

• Ability to work in a manufacturing environment with exposure to equipment, chemicals, and cleaning agents.
• Occasional lifting of up to 30 lbs.
• May require work in cleanroom environments and adherence to specific health and safety protocols.
• Availability to address critical equipment issues and work during business hours.
  
  
  

Salary Range: $72,282 - $99,388

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.