Validation Engineer – FDA/GMP Protocols & Validation Plans

The Association of Technology, Management and Applied Engineering; Charlotte (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

The Association of Technology, Management and Applied Engineering is seeking a Validation Engineer to develop and execute validation plans in accordance with FDA and cGMP standards. The role involves preparing IQ/OQ/PQ protocols, VSRs and SOPs, and performing system walkdowns with changes managed through formal change control.

The position requires a Masters degree in a relevant field and willingness to travel to client worksites across the USA, with on-site work in Charlotte, NC.

Qualifications

• Master’s degree in a relevant field (e.g., CS, Engg, Tech, Mgmt, Chemistry or related Analytical Science).
• Experience with FDA, cGMP standards and validation.
• Experience developing and executing Validation Plans (VP), Protocols (IQ/OQ/PQ) and Validation Summary Reports (VSR).
• Experience creating Standard Operating Procedures (SOPs).
• Ability to perform system walkdowns and implement changes via change control.

Responsibilities

• Develop and execute Validation Plans (VP) and Validation Protocols (IQ/OQ/PQ).
• Prepare Validation Summary Reports (VSR) and SOPs.
• Perform system walkdowns and manage changes through change control processes.

Skills

Validation

Documentation

Change control

QA

Education

Master's degree

Job description

The Association of Technology, Management and Applied Engineering is seeking a Validation Engineer to develop and execute validation plans in accordance with FDA and cGMP standards. The role involves preparing IQ/OQ/PQ protocols, VSRs and SOPs, and performing system walkdowns with changes managed through formal change control.

The position requires a Masters degree in a relevant field and willingness to travel to client worksites across the USA, with on-site work in Charlotte, NC.