System Engineer

System Engineer - Contract - Gaithersburg, MD

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

Primary Responsibilities:

This role focuses on supporting the design and operation of major facility systems and critical utilities, ensuring optimal function of all manufacturing, laboratory, and building spaces. The successful candidate will work closely with various teams to meet user requirements and maintain operational excellence.

Skills & 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.

The System Engineer's responsibilities will be:

• Create and maintain Drawing Management Programs, including CAD files, construction drawings, controlled drawings, and schematics.
• Develop equipment layout and floor plans, including space and utility planning, room numbers, and seating charts.
• Coordinate data collection and incorporate information into drawings, schematics, and maps.
• Support site assessments, including property condition assessment reports, 3D scanning, and retro commissioning.
• 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.
• Ensure project requirements meet current GMP, GLP, and EHS standards and practices.
• Support facilities and engineering project activities, including developing user requirement specifications, FAT, SAT, and commissioning/validation.

Compensation:

• $70,000 to $80,000 per annum

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.