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 compliance with FDA and other relevant regulations.

Responsibilities

• Develop and execute validation plans for new and existing products and processes
• Collaborate with cross-functional teams to ensure alignment on validation strategies and timelines
• Lead validation studies and document findings in accordance with Good Laboratory Practice (GLP) and other applicable guidelines
• Support the implementation and maintenance of validation systems and procedures
• Contribute to the continuous improvement of validation processes and methodologies

Requirements

• Bachelor's degree in a related field such as Biotechnology, Chemistry, Engineering, or a related technical discipline
• Minimum 5 years of experience in validation engineering or a related field
• Experience with FDA regulations and GLP guidelines
• Strong knowledge of statistical analysis and data interpretation
• Excellent communication and collaboration skills

Qualifications

• Ability to work independently and as part of a team
• Proficiency in Microsoft Office Suite
• Experience with validation software tools (e.g., VxL, VxS)

Skills

• Validation engineering
• Statistical analysis
• Regulatory compliance
• Team leadership

Benefits

• Competitive salary
• Health insurance
• 401(k) plan
• Flexible work schedule
• Professional development opportunities

Pay

• $80,000 - $120,000 annually

Schedule

• Monday to Friday, 9:00 AM - 5:00 PM