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QMS3 weeks ago

Facility Engineer

On-site · Piscataway, New Jersey, United States

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown

Job Summary

Facility Engineer responsible for developing, testing, modifying, and creating engineered solutions to technical problems in a GMP environment. Duties include maintaining facility equipment and utilities, overseeing validation and calibration activities for biologics operations (documentation such as protocols, test scripts, deviations, draft SOPs), supporting long-range reliability improvement programs, producing engineering documents for equipment and utilities, selecting/installing new equipment, performing thermal mapping on freezers/refrigerators, updating PM and calibration master lists, creating AutoCAD drawings and performing load calculations (Trace 700), managing lab gas supply and alarms, coordinating with vendors, supporting EHS programs, and ensuring GMP-compliant documentation and procedures. Requires coordination across Manufacturing, Analytical R&D, QA, Microbiology, Engineering, Supply Chain, and HR, with travel minimal (up to 25%) and potential for night/weekend work as needed. Education and experience as specified above guide the role.

Required Qualifications

  • Bachelor's degree in Engineering preferred
  • Minimum 1-3 years engineering experience in GMP environment
  • Experience with OSHA, EPA, FDA, and local authority jurisdictions required
  • Excellent oral and written communication skills required
  • Ability to work independently with minimal direct supervision required
  • Computer literate and proficient in Microsoft Word, Excel, Outlook, Project, PowerPoint, etc.
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QMS

Facility Engineer

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