Senior Validation Engineer

1 week ago


Devens, Massachusetts, United States Omni Inclusive Full time
Job Summary

Omni Inclusive is seeking a highly skilled Senior Validation Engineer to lead the qualification of quality control equipment and its associated software. As a key member of our team, you will be responsible for designing, executing, and managing qualification documents, including user requirement specifications, design qualification, and validation plans. Your expertise in computer system validation and quality management systems will be essential in ensuring compliance with regulatory requirements and industry standards.

Responsibilities

Design and execute qualification documents for quality control equipment and software
Manage and implement qualification plans, including user requirement specifications and design qualification
Author and execute computer system validation scripts
Own change controls for qualification of quality control instruments and software
Update asset management database to reflect new assets, calibrations, and preventative maintenances
Author instrument operational SOPs as needed
Coordinate with vendors and liaise with Digital Plant and lab departments
Champion qualification deviations and software defects, identifying root causes and corrective actions

Requirements

Bachelor's degree in a relevant scientific, engineering, or computer-based field
6-10+ years of experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience
Quality management system experience, including document control, change controls, and electronic validation databases
Knowledge of cGMP regulatory requirements, computerized analytical systems, and data integrity
Strong communication and collaboration skills, with experience in cross-functional influencing
Working knowledge of laboratory systems, including Empower and NuGenesis, and Microsoft Office Applications
Must have equipment validation experience, GMP experience, and Quality Management System experience
Experience in Computer System Validation and asset management software is a plus

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