Senior Validation Engineer

About the role

The Senior Validation Engineer will be responsible for ensuring that all systems and processes meet regulatory requirements. This includes designing, implementing, and validating testing protocols to ensure product quality.

Responsibilities

• Design and implement validation plans for new and existing products and processes.
• Collaborate with cross-functional teams to ensure compliance with FDA and other regulatory standards.
• Lead validation projects from initiation through completion, including planning, execution, and reporting.
• Perform risk assessments and develop mitigation strategies to address potential deviations from validated procedures.
• Train team members on validation methodologies and ensure adherence to established protocols.

Requirements

• Bachelor's degree in a related field such as Biomedical Engineering, Chemical Engineering, or a related technical discipline.
• 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, particularly Excel and PowerPoint.
• Ability to work independently and as part of a team.

Qualifications

• Experience with validation software tools such as VxL or VxL Pro.
• Knowledge of cGMP and ISO standards.
• Experience with automation and robotics in manufacturing environments.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to manage multiple tasks and prioritize effectively.
• Experience with data analysis and interpretation.

Benefits

• Competitive salary commensurate with experience.
• Health, dental, and vision insurance.
• 401(k) retirement plan with company match.
• Flexible work schedule.
• Professional development opportunities.

Pay

• Salary range: $80,000 - $120,000 annually.

Schedule

• Full-time position.
• On-site work required.