Validation Engineer

Itminds; Ashburn (GA); Presencial; USD 80.000 - 100.000; Jornada completa

Descripción de la vacante

A leading technology company in Ashburn, VA is seeking a skilled Validation Engineer to develop validation protocols and ensure compliance with FDA regulations and internal quality standards. The ideal candidate will have a Bachelor's degree in a related field and a minimum of 5 years of experience in validation. This role involves preparing Validation Master Plans, executing validation activities, and ensuring data integrity. Excellent analytical and communication skills are essential.

Formación

• Minimum of 5 years of experience in validation or a related occupation.
• Strong understanding of FDA regulations and cGMP requirements.
• Experience with CAPA systems and deviation handling preferred.

Responsabilidades

• Prepare Validation Master Plans and author validation protocols (IQ, OQ, PQ).
• Execute validation activities and manage associated processes.
• Monitor and ensure data integrity; compile and analyze data.

Conocimientos

Analytical skills

Documentation skills

Communication skills

Educación

Bachelor’s degree in Science, Technology, Engineering, or related field

Descripción del empleo

Location: Ashburn, VA

Job Type: Full time

Job Description:

We are seeking a skilledValidation 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.

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.

Qualifications

• Bachelor’s degree in Science, Technology, Engineering, or related field.
• Minimum5 years of experiencein 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.