Senior Validation Engineer

About the role

The Senior Validation Engineer will be responsible for ensuring that all products and processes meet regulatory requirements. This includes designing, implementing, and validating testing protocols, as well as leading validation projects from start to finish.

Responsibilities

• Design, implement, and validate testing protocols for new and existing products and processes.
• Lead validation projects from concept through completion, including planning, execution, and reporting.
• Collaborate with cross-functional teams to ensure compliance with regulatory standards and company policies.
• Document validation activities and results in accordance with Good Laboratory Practice (GLP) guidelines.
• Perform risk assessments and develop mitigation strategies for potential deviations or non-conformities.
• Train team members on validation procedures and maintain training records.

Requirements

• Bachelor's degree in a relevant field such as Biomedical Engineering, Chemistry, 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 interpersonal skills.
• Ability to work independently and manage multiple projects simultaneously.

Qualifications

• Proficiency in Microsoft Office Suite, particularly Excel and PowerPoint.
• Experience with validation software tools such as VxL or VxL Pro.
• Knowledge of quality management systems (QMS) and ISO 13485.

Skills

• Strong analytical and problem-solving skills.
• Ability to prioritize tasks and manage time effectively.
• Attention to detail and ability to work under pressure.
• Strong written and verbal communication skills.

Benefits

• Comprehensive health insurance coverage.
• Flexible work schedule options.
• Professional development opportunities.
• Employee assistance program.
• Discounted gym memberships and wellness programs.

Pay

Competitive salary commensurate with experience.

Schedule

Full-time position with flexible working hours.