Validation Engineer

About the role

The Validation Engineer will be responsible for ensuring that all processes and systems meet regulatory requirements through the implementation and maintenance of validation programs.

Responsibilities

• Develop and execute validation plans for new and existing processes and systems.
• Perform risk assessments to identify potential deviations and develop corrective actions.
• Collaborate with cross-functional teams to ensure compliance with FDA and other regulatory standards.
• Document validation activities and maintain validation records in accordance with company policies and regulations.
• Support investigations related to non-conformities and deviations from validated processes.

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 validation methodologies and techniques.
• Excellent problem-solving and analytical skills.
• Ability to work independently and as part of a team.

Qualifications

• Knowledge of software tools for validation process documentation and execution.
• Experience with statistical analysis and data interpretation.
• Proficiency in Microsoft Office Suite.

Skills

• Strong communication and interpersonal skills.
• Ability to manage multiple projects simultaneously.
• Attention to detail and ability to work under pressure.

Benefits

• Comprehensive health insurance coverage.
• Flexible work schedule options.
• Professional development opportunities.
• Employee discounts on products/services.

Pay

Competitive salary commensurate with experience.

Schedule

Full-time position with flexible working hours.