Senior Validation Engineer

About the role

The Senior Validation Engineer will be responsible for ensuring that all products and processes meet regulatory requirements through the validation lifecycle. This includes planning, executing, and documenting validation studies to ensure product quality and compliance.

Responsibilities

• Develop and execute validation plans for new and existing products and processes.
• Collaborate with cross-functional teams including R&D, manufacturing, and QA to ensure alignment on validation strategies.
• Perform risk assessments and develop mitigation strategies for validation activities.
• Document validation activities in accordance with FDA guidelines and company standards.
• Support investigations related to deviations from validated procedures.
• Ensure adherence to Good Manufacturing Practices (GMP) and other relevant regulations.

Requirements

• Bachelor's degree in a scientific field such as Biomedical Engineering, Chemical Engineering, or a related field.
• Minimum 5 years of experience in validation engineering or a related field.
• Experience with FDA regulations and GMPs.
• Strong knowledge of statistical methods and data analysis tools.
• Excellent communication and collaboration skills.
• Ability to work independently and manage multiple projects simultaneously.

Qualifications

• Knowledge of validation methodologies and techniques.
• Experience with validation software tools such as VxL, VxL Express, or similar.
• Experience with process validation and equipment qualification.
• Understanding of cGMP principles and their application in a pharmaceutical setting.

Skills

• Proficiency in Microsoft Office Suite.
• Strong problem-solving and analytical skills.
• Ability to work in a fast-paced, dynamic environment.

Benefits

• Comprehensive health insurance coverage.
• Flexible work schedule options.
• Professional development opportunities.
• Employee assistance program.

Pay

$80,000 - $120,000 annually based on experience.

Schedule

Monday through Friday, 8:00 AM - 4:30 PM.