Validation Engineer

Avispa Technology•Tucson, AZ

2d•Onsite

About The Position

A leading music streaming company seeks a Validation Engineer ROCGJP00040514 to support process validation activities in a regulated manufacturing environment. This role will focus on ensuring compliance, supporting operational integrity, and driving continuous improvement initiatives within FDA-regulated operations.

Requirements

Bachelor’s Degree in Engineering or Life Science.
Strong understanding of process validation principles, methodologies, and industry standards.
Knowledge of cGMP, FDA, ISO, and related regulatory requirements.
Strong technical writing, analytical, troubleshooting, and problem-solving skills.

Nice To Haves

1-3 years of experience in a regulated manufacturing environment, such as medical devices, pharmaceutical, or biotech industries, is preferred.

Responsibilities

Develop, review, and execute process validation and process verification protocols, reports, and supporting documentation for new and existing manufacturing processes.
Conduct risk assessments, analyze validation data, and ensure compliance with FDA, ISO, cGMP, and internal quality and regulatory requirements.
Collaborate cross-functionally with Manufacturing, Quality, and Design Transfer Operations teams to resolve validation issues, implement corrective actions, and support process optimization initiatives.
Maintain validation documentation and traceability for audits and inspections while providing training and guidance to manufacturing and quality personnel on validation procedures and best practices.
Support continuous improvement efforts and additional validation or quality-related projects as assigned by management.