Validation Engineer/Specialist (Atlanta, Georgia)

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services. - 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 Education: - B.S. Engineering (e.g. Computer Science, Chemical, Mechanical, Electrical, etc.)Minimum Skills: - 3-5 years hands-on validation experience (writing and execution of validation protocols) - Capable of working independently with minimal supervision, and communicating with project team members to assure timelines are met - Great technical writing and communication skills - Proficiency in Microsoft Office application (Word, Excel and Project) - Effective interpersonal and problem solving skills - Demonstrate excellence in good documentation requirements and attention to detail Positions available for Puerto Rico. Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.