Validation Engineer

About the role

The Validation Engineer will be responsible for ensuring that products and processes meet established quality standards through the implementation and maintenance of validation programs.

Responsibilities

• Develop and execute validation plans for new and existing products and processes.
• Perform risk assessments to identify potential failure modes and develop mitigation strategies.
• Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
• Document validation activities and results in accordance with company and regulatory guidelines.
• Support the continuous improvement of validation processes and methodologies.

Requirements

• Bachelor's degree in Engineering, Quality Assurance, or a related field.
• Minimum 5 years of experience in validation engineering or a related field.
• Experience with FDA regulations and Good Manufacturing Practices (GMP).
• Strong knowledge of statistical process control (SPC) and Six Sigma principles.
• Proficiency in Microsoft Office Suite, including Excel and PowerPoint.

Qualifications

• Ability to work independently and as part of a team.
• Excellent communication and problem-solving skills.
• Ability to manage multiple projects simultaneously.
• Knowledge of automation tools and software.

Skills

• Strong analytical and problem-solving skills.
• Experience with validation software such as VxView or VxView Pro.
• Knowledge of cGMP and FDA regulations.
• Experience with Lean and Agile methodologies.

Benefits

• Comprehensive health insurance coverage.
• Flexible work schedule.
• 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.