Senior Validation Engineer

About the role

The Senior Validation Engineer will play a critical role in ensuring the quality and reliability of our products through comprehensive validation processes. This position requires a deep understanding of validation methodologies and a proven track record in leading validation projects.

Responsibilities

• Develop and execute validation plans for new and existing products
• Collaborate with cross-functional teams to ensure compliance with regulatory standards
• Lead validation project teams and manage timelines and budgets
• Perform risk assessments and develop mitigation strategies
• Document validation activities and results in accordance with regulatory guidelines
• Train team members on validation procedures and best practices

Requirements

• Bachelor’s degree in a relevant field (e.g., Biomedical Engineering, Chemical Engineering, Quality Assurance)
• Minimum 5 years of experience in validation engineering
• Experience with FDA and ISO regulations
• Strong knowledge of validation methodologies and techniques
• Excellent communication and leadership skills
• Ability to work independently and as part of a team

Qualifications

• Proficiency in Microsoft Office Suite
• Experience with statistical software (e.g., Minitab, JMP)
• Knowledge of cGMP principles

Skills

• Strong analytical and problem-solving skills
• Effective written and verbal communication skills
• Ability to prioritize tasks and manage multiple projects simultaneously
• Experience with GAMP 5 or similar frameworks

Benefits

• Competitive salary commensurate with experience
• Health insurance coverage
• Paid time off
• Professional development opportunities

Pay

Commensurate with experience

Schedule

Full-time, Monday through Friday