Validation Engineer/ Specialist

Validation & Engineering Group • Johns Creek, GA

77d

About The Position

The Validation Engineer/ Specialist will be responsible for all validation activities for the assigned project. This project includes the validation of multiple autoclaves and temperature controllers. Validation scope may include: Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, C&Q activities, among others.

Requirements

• Bachelor degree in Engineering or Science
• 5 to 10 years of experience in the medical device, biotechnology or pharmaceutical industry
• Experience validating autoclaves
• Experience with Validation Life Cycle (Process, Packaging and Cleaning)
• Knowledge of regulations, including GMP
• Experience developing and conducting efficient processes to meet production demands
• Excellent technical writing and verbal communication skills
• Detail-oriented with the ability to identify milestones
• Strong interpersonal and communication skills
• Proficiency in MS Office Suite (Word, Excel, PowerPoint)
• Availability to work extended hours and holidays if required
• Willingness to travel and work non-standard shifts if necessary

Nice To Haves

• Experience in liquid dosage validation
• Bilingual (Spanish & English)

Responsibilities

• Conduct validation activities for assigned projects
• Validate multiple autoclaves and temperature controllers
• Manage Validation Life Cycle, Execution, and Technical Documentation
• Perform GAP Analysis and Risk Assessment
• Execute C&Q activities

What This Job Offers

• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees