We are seeking a Site Engineer 1 to work in our Gaithersburg, MD Engineering group. This position will have an area of focus on supporting the design and operation of major facility systems and critical utilities, supporting operational space and utility process conditions. This position reports directly to the Manager of Site Engineering but works closely with all members of the Engineering, Quality, IT, Validation, Facilities, Lab Operations, and the Manufacturing Operations groups to meet user requirements and optimal function of all Manufacturing, Laboratory and Building Space criteria
Essential Functions
Responsible for creating and maintaining Drawing Management Programs. Including CAD Files, Construction Drawings, Controlled Drawings, 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 The 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.
Required Knowledge, Skills, and Abilities
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. This does not include the ability to execute computer/IT programming but the understanding of building automation systems and process/equipment control systems.
Experience with cGMP Quality Systems in a biotech/pharmaceutical environment. This includes experience with authoring and executing equipment/system Change Controls, Deviations, and CAPAs.
Knowledge of FDA regulatory requirements.
Education, Experience, Licenses & Certifications
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.