Validation Engineer

Location: Ashburn, VA

Job Type: Full time

Job Description:

We are seeking a skilled Validation Engineer to join our team. The ideal candidate will be responsible for developing and implementing validation protocols and ensuring compliance with FDA regulations and internal quality standards.

Key Responsibilities:

• Prepare Validation Master Plans and author validation protocols (IQ, OQ, PQ) in accordance with FDA regulations.
• Execute validation activities and manage associated processes, including change controls, CAPA, and deviation records.
• Monitor and ensure data integrity; compile and analyze data for summary reports and trend analysis.
• Support regulatory audits and internal self-inspections.
• Ensure compliance with applicable Standard Operating Procedures (SOPs) and quality requirements.

Requirements:

• Bachelor’s degree in Science, Technology, Engineering, or related field.
• Minimum 5 years of experience in validation or a related occupation.
• Strong understanding of FDA regulations and cGMP requirements.
• Experience with CAPA systems, deviation handling, and audit readiness is preferred.
• Excellent analytical, documentation, and communication skills.