Job Title: Validation Engineer

Work Location: Wake County, North Carolina

Summary:

This role focuses on ensuring robust validation processes within regulated manufacturing environments, emphasizing compliance, technical documentation, and risk-based approaches.

Responsibilities:

• Lead and execute process and cleaning validation activities, ensuring compliance with regulatory standards.
• Develop, review, and maintain validation protocols, reports, and supporting documentation.
• Apply risk-based validation methodologies to optimize validation strategies and outcomes.
• Support investigations and regulatory documentation related to validation in a GMP-regulated setting.
• Ensure adherence to EU GMP Annex 1 requirements and maintain up-to-date knowledge of compliance expectations.
• Collaborate with cross-functional teams to support aseptic manufacturing operations and validation needs.
• Contribute to contamination control strategies and lifecycle validation concepts as part of continuous improvement initiatives.
• Provide technical expertise for validation activities involving polymer-based products and pre-filled syringe manufacturing lines.

Qualifications:

• Strong experience in process validation and cleaning validation.
• Excellent technical writing and documentation skills.
• Thorough understanding and application of risk-based validation approaches.
• Experience in aseptic manufacturing environments.
• Working knowledge of EU GMP Annex 1 requirements and compliance expectations.
• Ability to effectively support validation protocols, reports, investigations, and regulatory documentation in a GMP-regulated environment.
• Experience with polymer-based products and processes is a plus.
• Experience supporting pre-filled syringe manufacturing lines is preferred.
• Familiarity with contamination control strategies and lifecycle validation concepts is advantageous.

Published Category: Quality & Validation