Validation Engineer

About the role

The Validation Engineer is responsible for ensuring that all processes and systems meet established quality standards. This includes designing, implementing, and validating testing procedures to ensure product quality.

Responsibilities

• Develop and execute validation protocols for new and existing products and processes.
• Collaborate with cross-functional teams to identify and resolve validation issues.
• Perform risk assessments and develop mitigation strategies for potential validation risks.
• Train team members on validation procedures and ensure compliance with regulatory requirements.
• Document validation activities and maintain records in accordance with company policies and regulatory guidelines.

Requirements

• Bachelor's degree in Engineering, Science, or 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 and other relevant software tools.

Qualifications

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

Skills

• Validation methodologies and techniques.
• Statistical analysis and data interpretation.
• Project management and leadership skills.
• Regulatory compliance and documentation.

Benefits

• Competitive salary package.
• Paid time off and holidays.
• Health, dental, and vision insurance.
• Flexible work schedule.
• Professional development opportunities.

Pay

• $80,000 - $120,000 annually.

Schedule

• Full-time position.