Quality Engineer - Validation

Quality Engineer (Validation)

Overview

A medical device org is seeking a Quality Engineer to support a major manufacturing capacity expansion program in Jacksonville, FL. This project involves the transfer and qualification of production lines from the overseas into the Jacksonville facility, supporting growth across the contact lens manufacturing operation. The Quality Engineer will primarily support equipment qualification and validation activities, working alongside established senior SMEs who will provide guidance, training, and technical oversight.

Responsibilities

• Support equipment qualification activities for transferred and newly installed manufacturing equipment
• Review validation documentation and protocols (not responsible for authoring protocols)
• Participate in:
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Process Validation activities
• Risk assessments
• Procedural revisions and updates
• Work closely with Quality, Engineering, Manufacturing, and Validation teams during equipment startup and qualification
• Support deviation investigations and validation execution activities as required
• Ensure compliance with applicable quality and regulatory standards

Required Experience

• 1-5+ years of Quality Engineering, Validation Engineering, or similar experience within a regulated manufacturing environment
• Experience supporting:
• IQ/OQ/PQ activities
• Equipment qualification
• Validation reviews
• Risk assessments
• Understanding of GMP, validation, and quality system requirements
• Experience within a regulated industry such as:
• Medical Device
• Pharmaceuticals
• Biotechnology
• Automotive
• Aerospace
• Other highly regulated manufacturing environments

Preferred Experience

• Computer System Validation (CSV) exposure
• Experience validating:
• Automated or semi-automated manufacturing equipment
• Production recipes
• User access controls
• Alarm management systems
• Experience supporting manufacturing line transfers, scale-up programs, or capacity expansion projects
  

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com