Clean Utilities Technician

Clean Utilities Technician
College Station, Texas 77845 - US

Job Description

Relocation Costs will be covered

Summary:  The Clean Utilities Technician under the supervision of the Facilities Supervisor, will be the individual primarily responsible for day-to-day aspects of operating and maintaining the clean utilities in support of both the Biological Facility and the Flexible Biological Facility.  This position will be the lead technician for operation and maintenance, both routine and corrective, of the water purification systems including the Reverse Osmosis water purification skids, the Mar-Cor water pretreatment skids, and the Mueller ultrapure water distillation units, producing pure water (Water for Injection, USP).   These systems provide ultrapure water to two biological vaccine facilities through ultrapure piping and distribution systems. 

Responsibilities:

  • Responsible for generation skids for Pure Steam generation and distribution. 
  • Support maintenance for other equipment which consumes clean steam and pure water, such as washers and autoclaves and will work with other maintenance and technical trades to maintain these systems in GMP condition, including calibration, quality control and validation, as well as manufacturing. 
  • Will support the Facilities Supervisor and the Environment, Health and Safety personnel (EHS) to ensure the systems are operated safely and within limits.  

Essential Functions:

  • Responsible for taking the lead in the day-to-day operations of the clean utilities, planning  scheduled shutdowns for maintenance, scheduling off-site vendors, if required, and selecting, ordering and maintaining adequate spare parts and supplies. 
  • Responsible for monitoring the condition of the equipment to anticipate any future failure modes or conditions and correcting or recommending corrective actions.  
  • Understand and communicate with others regarding the condition of the systems and possible effects of failure modes on users of the systems.  
  • Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility.
  • Able to work with other engineers and quality control personnel regarding changes or expansions to the system.
  • Assist in writing SOPs for maintenance actions, including regeneration and sanitization of the clean utility systems mentioned above. 
  • Comply with Quality System requirements for Deviations and Change Controls when required.

Required Skills & Abilities:

  • Strong understanding of GMP requirements for clean utility systems. 
  • Knowledge of a wide variety of typical maintenance tasks on clean systems, including water purification, water distillation, clean steam generation, general principles of engineering, operations and maintaining clean utilities and the tools and equipment required to perform many of the daily maintenance tasks.
  • Strong written, verbal and interpersonal communications skills.  Must be able to develop and draft clear procedures for operations and maintenance documentation.
  • Desire to work in a fast paced, state of the art, customized manufacturing facility.
  • Ability to work quickly and effectively without constant supervision.
  • Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint) as well as use of Computerized Maintenance Management System, CMMS.
  • Knowledge of GMP requirements and procedures, predisposed to documentation of work performed, documenting non-conformance conditions and maintaining clean work areas.

Contact:  James Shih (201) 843-4400 ext. 225

 

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