Validation Engineer/Specialist (Atlanta, Georgia)

• 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

Qualifications

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

Additional Information

Positions available for Puerto Rico.

Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.

About the Company

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.