Validation Engineer Job in Atlanta, Georgia US

We are currently seeking an Engineer to coordinate validation aspects of project to support a growing, fast paced pilot manufacturing medical device manufacturer. This individual will manage various engineering activities assigned in the development of lifecycle documents for a large, established medical device manufacturing cleaning validation program.  Tasks include: determining surface area calculations of all identified product contact areas and determining material(s) of construction (including grade/type) of all identified product contact areas, and assessing and creating dimensional CAD drawings in AutoCAD or Solidworks format for all identified product contact areas that are not in the site's drawing database.   Must abide by corporate policies and procedures relating to quality, process development, and IQ/OQ for achieving reliability in accordance with specifications and procedures.   Document qualifications/validations to ensure company guidelines are being met according to 21CFR Part 11.     

 

Job Requirements:

Minimum of a Bachelor’s Degree in Engineering, Architectural or Material Science and 3 years hands-on validation and process improvement experience according to 21CFR Part 11 Requirements; preferably pharmaceutical or medical device field with knowledge of current Good Manufacturing Practices and Quality System Regulations.   Background should entail recent industrial work experience within an FDA manufacturing plant with proven implementation and validation of cleaning programs to include:  surface area calculations, material(s) of construction determination, and/or CAD.

Other skills to include: 

·  ASQ CQE certification preferred, not required.

·  Personal computer skills, i.e., word processing, spreadsheets, data analysis.

·  Must have high degree of stability, good emotional control, good interpersonal skills, and excellent expression (both oral and written.)

·  Must be self-starter, open-minded, flexible, and able to adapt easily and accept new ideas quickly.

·  Must be able to maintain a high activity level and be able to effectively manage and prioritize numerous projects and responsibilities.