Clean Utilities Technician

5 days ago


Durham, North Carolina, United States BioSpace, Inc. Full time
About the Role

We are seeking a highly skilled Clean Utilities Technician to join our team at BioSpace, Inc. This is a critical role that requires a strong understanding of clean utilities systems and their operation in a regulated manufacturing environment.

Key Responsibilities
  • Operate and maintain mechanical equipment used in a regulated manufacturing environment, including purified water, WFI, clean steam, and process compressed air systems.
  • Monitor daily utility system performance and identify areas for improvement.
  • Perform routine walk-throughs of areas of support and troubleshoot problems on purified water skids, WFI, clean steam, PCA, pumps, motors, and valves.
  • Support utility systems under your responsibility, understanding GMP utility applications in aseptic manufacturing.
  • Ensure utility systems efficiency, availability, and performance.
  • Collaborate with Clean Utilities Engineers on process flow and controls of process parameters.
  • Communicate with internal stakeholders in case of system issues and understand their needs.
  • Ensure a safe working environment by following safety rules and contributing to a positive safety culture.
  • Participate in identifying opportunities to improve quality and reliability and lead small projects in your area of support.
  • Provide input into capital projects targeting short- and long-term needs and support the delivery of small projects in your area.
  • Responsible for equipment reliability issues and maintenance strategy, ensuring work orders are correctly closed before the due date and maintenance programs are adequately implemented.
  • Participate in ensuring planned or unplanned maintenance activities are scheduled and executed effectively.
  • Interface with external contractors as needed.
Requirements
  • Experience with clean utilities systems.
  • Relevant experience operating in an FDA-regulated manufacturing environment.
  • At least 2 years of experience in engineering and/or maintenance.
Preferred Qualifications
  • Associate degree in engineering or a technical field.
  • Strong problem-solving skills.
  • Good interpersonal and communication skills.
  • Ability to work effectively in a cross-functional environment.
  • Ability to communicate effectively with all levels of the organization.
  • Strong computer skills in various software packages, including SAP, Trackwise, MS Word, Excel, and Computerized Maintenance Management Systems (CMMS).
  • Previous facility start-up experience.
  • Previous equipment commissioning, qualification, and process validation experience.
  • Previous experience with deviation and change management systems, including Trackwise.
  • Reliability Centered Maintenance (RCM) exposure/knowledge/experience.
  • Parenteral manufacturing experience.
  • Plant engineering experience.
  • MAXIMO or similar CMMS system experience.


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