Validation Engineer/Specialist (Atlanta, Georgia)

Validation Engineer/Specialist responsible for planning and integration of Commissioning and Qualification activities in medical device manufacturing, equipment qualification and process validation, and computerized system validation.

Requirements

• Expertise in "Risk Based Approach" for Commissioning and Qualification practices
• Planning and Integration of Commissioning and Qualification activities in medical device manufacturing (Class II preferred)
• Risk Management practices (i.e. Assessments, Functional Risk Documents, pFMEA, etc.)
• Equipment qualification and process validation
• Computerized System Validation (PLC, HMI, etc.)
• 21 CFR Part 11 requirements and how to incorporate these requirements into an efficient testing strategy
• Assist in deviation investigation and resolution for problems and issues encountered during field execution activities

Benefits

• Equal Employment Opportunity employer