CQV Lead

Job Summary:

We are seeking an experienced CQV Lead to join our team, focusing on filling lines support. The role will be responsible for leading commissioning, qualification, and validation activities for pharmaceutical filling lines while ensuring compliance with cGMP requirements and industry standards.

Key Responsibilities:

• Lead and oversee CQV activities for filling line equipment and systems
• Develop and review validation master plans, protocols, and reports
• Manage validation teams and coordinate with cross-functional departments
• Ensure compliance with quality standards and regulatory requirements
• Provide technical expertise in troubleshooting and problem-solving
• Lead risk assessments and impact evaluations
• Mentor junior validation engineers and team members

Required Qualifications:

• Bachelor's degree in Engineering, Science, or related field
• 8+ years of relevant experience in pharmaceutical/biotech CQV
• Extensive knowledge of aseptic filling operations and equipment
• Experience with validation lifecycle approach and risk-based validation
• Strong leadership and communication skills

Preferred Qualifications:

• Experience with automated filling systems
• Knowledge of data integrity requirements
• Six Sigma certification
• Experience with computer system validation

**Weil Group is proud to be an Equal Employment Opportunity Employer.**