Validation Engineer

Burke Porter, an Ascential Technologies Brand•Andover, MN

2d•$90,000 - $105,000

About The Position

The Validation Engineer supports the design, implementation, and continuous improvement of equipment validation and asset lifecycle programs. The role manages qualification and validation activities for facilities, equipment, instruments, systems, and software. The engineer develops and approves validation master plans, IQ/OQ/PQ protocols, and summary reports, ensuring documentation meets regulatory and internal quality standards. They oversee and execute validation protocols, collect and analyze data, and interpret results to confirm equipment performance, reliability, and compliance. The position ensures validation activities comply with FDA, EU, ICH, ISO, and other relevant standards. It also leads risk assessments, such as FMEA, and implements mitigation strategies. The engineer collaborates with Manufacturing, Facilities, Quality Assurance, IT, Program Management, and external clients to support validation projects and resolve technical issues. They manage requalification and revalidation after equipment changes, upgrades, or periodic reviews, and maintain validated-state documentation and change-control records.

Responsibilities

Support the design, implementation, and continuous improvement of equipment validation and asset lifecycle programs.
Manage qualification and validation activities for facilities, equipment, instruments, systems, and software.
Author and approve validation master plans, IQ/OQ/PQ protocols, and summary reports.
Ensure documentation meets regulatory and internal quality standards.
Oversee and execute validation protocols, ensuring accurate data collection and analysis.
Interpret results to confirm equipment performance, reliability, and compliance.
Ensure validation activities comply with FDA, EU, ICH, ISO, and relevant standards.
Conduct and lead risk assessments, such as FMEA, to identify potential failure modes and implement mitigation strategies.
Partner with Manufacturing, Facilities, Quality Assurance, IT, Program Management, and external clients to support validation projects and resolve technical issues.
Manage requalification and revalidation following equipment changes, upgrades, or periodic reviews.
Maintain validated-state documentation and change-control records.