Site Operations Specialist

4 weeks ago

Gaithersburg MD USA, United States Proclinical Staffing Full time
System Engineer - Contract - Gaithersburg, MD

Proclinical is seeking a skilled System Engineer to join a dedicated Engineering team in Gaithersburg, MD.

Key Responsibilities:
  • Support the design and operation of major facility systems and critical utilities to ensure optimal function of all manufacturing, laboratory, and building spaces.
  • Collaborate with various teams to meet user requirements and maintain operational excellence.
  • Develop and maintain Drawing Management Programs, including CAD files, construction drawings, controlled drawings, and schematics.
  • Coordinate data collection and incorporate information into drawings, schematics, and maps.
  • Ensure documentation and drawing specifications comply with procedures and statutory requirements.
  • Coordinate with various teams to ensure cGMP and non-GMP facilities equipment and systems, including HVAC, process gases, cooling and heating systems, and electrical systems.
  • Develop SOPs and change controls for equipment, facility, and utilities setup, maintenance, and operation.
  • Support facilities and engineering project activities, including developing user requirement specifications, FAT, SAT, and commissioning/validation.
Requirements:
  • Bachelor's degree in Mechanical Engineering or a related field, or equivalent combination of education and experience in the design and modification of biotechnology or pharmaceutical production facilities.
  • Experience with cGMP quality systems in a biotech/pharmaceutical environment, including authoring and executing equipment/system change controls, deviations, and CAPAs.
  • Experience supporting major facility systems and critical utilities in an FDA/EMA regulated environment.
  • Experience in CAD design of facilities and process utilities.
  • Knowledge on developing and maintaining as-built construction drawing sets.
  • Working history with facility/process utility equipment validation, calibration, and risk assessments.
  • Strong technical problem-solving abilities for facility systems and utility equipment.
  • Understanding of building automation systems and process/equipment control systems.
  • Intermediate computer skills using MS Office suite and Office 365 cloud environment.
  • Knowledge of FDA regulatory requirements.
Compensation:
  • $70,000 to $80,000 per annum

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