Site Operations Specialist

13 hours ago


Gaithersburg, Maryland, United States Diati Staffing Full time
Job Title: Site Engineer

We are seeking a highly skilled Site Engineer to join our team in Gaithersburg, MD. As a Site Engineer, you will play a critical role in supporting the design and operation of major facility systems and critical utilities.

Key Responsibilities:
  • Responsible for creating and maintaining Drawing Management Programs, including CAD Files, Construction Drawings, Controlled Drawings, and Drawing Schematics.
  • Responsible for Equipment Layout and Floor Plans, including Space and Utility Planning, Room Numbers, and Seating Charts.
  • Coordinate the collection of data and incorporate this information into drawings, schematics, and maps.
  • Support Site Assessments, including Property Condition Assessment Reports, 3D Scanning, and Retro Commissioning throughout all buildings.
  • Coordinate with Facilities, Lab Operations, and Manufacturing Operations Group to ensure cGMP and non-GMP facilities equipment and systems, including HVAC, Process gases, cooling and heating systems, and electrical systems.
  • Develop Standard Operating Procedures (SOPs) and Change Controls pertaining to setup, maintenance, and operation of equipment, facility, and utilities.
  • Ensure project requirements embrace and meet current GMP, GLP, and EHS standards and practices.
  • Support Facilities and Engineering project activities, including assisting in the development of user requirement specifications, FAT, SAT, and commissioning/validation.
Requirements:
  • Experience as a member of a functional team, helping with on-site issues that present themselves on a day-to-day basis.
  • Experience supporting major facility systems and critical utilities within an FDA/EMA regulated environment.
  • Experience with AutoCAD and Revit.
  • Experience in CAD design of facilities and process utilities.
  • Experience with developing and maintaining As-Built Construction drawing sets.
  • Experience with facility/process utility equipment validation, calibration, and performing risk assessments.
  • Strong facility system and utility equipment technical problem-solving abilities.
  • Experience with automation systems is highly desired.
  • Experience with cGMP Quality Systems in a biotech/pharmaceutical environment.
  • Knowledge of FDA regulatory requirements.
Education and Experience:

Bachelor's Degree in Mechanical Engineering (or other related field) with 0-2 years of experience (or equivalent combination of education and experience) in the design and modification of biotechnology or pharmaceutical production facilities.



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