CQV Engineer

We are seeking a highly motivated and experienced CQV Engineer to join our team in Holly Springs, North Carolina. The CQV Engineer will be responsible for leading commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment.

Requirements

• Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical facilities and equipment.
• Conduct risk assessments and gap analyses to identify potential compliance issues and develop strategies to mitigate them.
• Lead and manage CQV project teams, including coordinating with internal and external stakeholders.
• Ensure compliance with all relevant regulations and guidelines, including FDA, EMA, and ICH.
• Generate and maintain CQV documentation, including protocols, reports, and standard operating procedures (SOPs).
• Troubleshoot and resolve technical issues related to CQV activities.
• Train and mentor junior CQV engineers and technicians.
• Participate in client meetings and provide regular updates on project progress.
• Continuously improve CQV processes and procedures to ensure efficiency and effectiveness.

Benefits

• Competitive salary
• Benefits package
• Opportunities for professional growth and development