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Facilities Supervisor

Employer
CoImmune, Inc.
Location
Durham, North Carolina
Start date
Feb 4, 2021

Scope: This position provides daily supervision and multi-discipline hands-on support for laboratory and cGMP manufacturing functions in an FDA regulated facility. Oversee daily operation and preventative maintenance of facility systems, utility systems, production/laboratory equipment and instrumentation. Monitor building automation, power generation, fire/security and housekeeping services to ensure compliance with FDA requirements.

Responsibilities:

  • Provide daily supervision for utility systems, production and laboratory equipment.  This includes troubleshooting and preventative maintenance for HVAC, compressed gases, emergency power generation, and building automation systems to minimize downtime.
  • Manage personnel and contractors to PM, troubleshoot, and maintain GMP process, laboratory equipment and building.
  • Ensure all facility corrective and preventive maintenance is performed at the highest standard levels according to company policies and procedures.
  • Provide daily oversight to maintenance of laboratory and cGMP production equipment including commissioning, installation, and preventive maintenance.
  • After hours on-call support (e.g., alarm response).
  • Responsible for ProCal CMMS system and maintenance of PM schedules and procedures
  • Maintain and keep facility equipment files current, including work orders, maintenance, and operational manuals for support documentation.
  • Maintain, track and operate test equipment.
  • Adhere to all applicable SOPs and procedures.
  • Assist in development and review/approval of Facilities technical documents including SOPs, CAPAs, Deviations, and Validation documents.
  • Provide alarm reporting and trend data to support batch release and investigations.
  • Manage ongoing Facilities improvement projects.
  • Assist supervisor in maintaining the department’s budgets and schedules, and with ensuring that performance requirements meet corporate objectives.
  • Adhere to safety rules and keep work area in a clean and orderly condition.
  • Other duties as required.

Qualifications:

  • Bachelor’s degree with a minimum 4 years of supervisory experience working in facilities operating under cGMP guidelines is required.
  • Basic understanding of electrical, mechanical, building monitoring systems. 
  • Engineering background and/or Siemens/Iconics BMS experience is strongly preferred.
  • Ability to use pallet lifts and hand trucks safely.
  • Fluent with Windows computer applications that involve entering and retrieving information from files and reports, word and excel software.
  • Demonstrated attention to detail.
  • Strong organizational skills and the ability to cope with rapidly changing schedules.
  • Ability and willingness to be regularly, predictably and reliably at work.

Physical Demands: Majority of work is physical in nature. Possess physical strength with ability to lift 40 pounds.  Stamina required to stand, walk, climb or step-up for long periods of time.

EOE

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