Clean Utilities Lead

Clean Utilities Lead
College Station, Texas 77845 - US

Job Description

Relocation costs will be covered

Summary:  The Clean Utilities Lead, under minimal supervision of the Associate Director/Director of Facilities will be responsible for leading the day-to-day aspects of operating and maintaining the clean utilities in support of both the Biological Facility and the Flexible Biological Facility FBF.   The Clean Utilities Lead will direct and coach technicians/contractors/others on the proper operation and maintenance, both routine and corrective, for the water purification systems including the Reverse Osmosis water purification skids, the Mar-Cor water pre-treatment skids, the Mueller ultrapure water distillation units, producing pure water (Water for Injection, USP) Clean Steam generators, clean compressed air and other utilities in support of two biological vaccine facilities through ultrapure piping and distribution systems. 

This position will:

  • Be responsible for taking the lead in developing, changing and documenting maintenance procedures and training associates in the proper execution of the procedures. 
  • Will support maintenance for other equipment which consumes clean steam and pure water, such as washers and autoclaves. 
  • Will work with other maintenance and technical trades, such as calibration, validation, and quality to maintain these systems in GMP condition. 
  • The individual in this position will work in support of the Environment, Health and Safety personnel (EHS) to ensure the systems are operated safely and within limits.  

Essential Functions:

  • Lead for the day-to-day operations of clean utilities.
  • Responsible for planning scheduled shutdowns for maintenance, scheduling off site venders (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 recommending corrective action.
  • Understand and communicate with others regarding the condition of the systems and the 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.
  • Work with other engineers and quality control personnel regarding changes or expansions to the system.
  • Responsible for developing, writing, and/or editing SOPs and operations / maintenance procedures 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, and ensuring team members are compliant with policies and regulations.

Required Skills & Abilities:

  • Strong understanding of cGMP requirements for clean utility systems with the ability to instruct and guide others on the requirements.
  • Experience with 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.
  • Proven ability to work in a fast paced, state of the art, customized manufacturing facility.
  • Ability to work quickly and effectively without constant supervision. This is a working lead position.
  • 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.

Qualifications:

  • Associates Degree in Engineering, Maintenance or Bio-Engineering, or related field, with four (4) years' relevant work experience with maintenance of clean utility systems; OR
  • High School Diploma or GED with six (6) years' of relevant maintenance experience in bio-pharma facility with the above listed equipment.
  • Experience with preventative maintenance development through the use of a GMP Computerized Maintenance management System (CMMS).

Preferred Qualifications:

  • Experience in other maintenance trades, such as HVAC&R.
  • Journeyman Electrician qualification or Stationary Boiler Operator's license.

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

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