Validation Engineer (Packaging/Labeling) - Remote

Overview

The Validation Engineer is responsible for coordinating and executing the validation of processes, equipment, materials, and software, ensuring that validations meet quality and regulatory requirements.

In Short

• Supervise validation technicians and support production validations.
• Prepare validation protocols (IQ/OQ/PQ/MVP) and reports.
• Coordinate validation activities through constant communication with departments and involved personnel.
• Negotiate start and end dates for validation efforts.
• Follow validation testing strategy and recommend process and product improvements.
• Support and participate in design reviews, peer reviews, team meetings, and process audits.
• Ensure closure of validation process issues.
• Train operational users as necessary.
• Manage tasks and activities of direct reports and evaluate their performance.
• Coordinate and organize project development and implementation.

Requirements

• Bachelor's degree in Engineering or related fields.
• 2+ years of experience in validation engineering processes.
• 1+ year working with FDA/ISO 13485 in a regulated environment.
• Knowledge of GMPs, Lean Manufacturing, and 5S.
• Able to manage multiple projects.
• Decision-making skills.
• Disciplined and organized.
• Sense of urgency.
• Asertive communication.
• Ability to resolve problems quickly and effectively.

Benefits

• Equal opportunity employer.
• Opportunity for career growth in a high-performing environment.
• Work with a resilient global team.
• Engage with a broad product portfolio in healthcare.
• Contribute to improving clinical, financial, and operational outcomes.