Job Description

Overview

Responsible for supporting validation and qualification activities throughout the full equipment and system lifecycle, ensuring compliance with regulatory and quality standards. This role assists in generating documentation, executing protocols, and supporting change control processes within a GMP-regulated environment.

Responsabilities

Perform qualification lifecycle activities, including planning, execution, and documentation of equipment and system qualification. Develop and execute validation and qualification protocols and reports. Generate and manage Change Control documentation in compliance with internal procedures and regulatory requirements. Support troubleshooting activities related to validation, qualification, and equipment performance issues. Ensure all activities comply with Good Manufacturing Practices (GMP) and applicable regulatory guidelines. Collaborate with cross-functional teams including Manufacturing, Packaging, Engineering, and Quality Assurance. Maintain accurate and complete validation documentation and records. Support audits and inspections by providing validation-related information as required.

Requirements

Education:

Bachelor's degree in Engineering, Science, or related technical field (or equivalent experience). Excellent technical writing and documentation abilities. Hands-on experience working in a GMP-regulated environment. Experience with manufacturing and packaging equipment validation is preferred. Knowledge of validation lifecycle methodologies and regulatory requirements (FDA, EU, etc.).
Work Location: In person