CQV Engineer

Holly Springs, North Carolina, United States

Pharm Eng Technology is a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries. We specialize in providing innovative solutions to our clients to help them achieve their goals in drug development, manufacturing, and compliance.

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.

• 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.

• Bachelor's degree in Engineering or related field.
• Minimum of 5 years of experience in CQV within the pharmaceutical or biotechnology industry.
• Strong knowledge of cGMP regulations and guidelines.
• Experience with commissioning, qualification, and validation of equipment and facilities.
• Excellent project management skills and ability to lead and manage project teams.
• Strong communication and interpersonal skills.
• Ability to work independently and in a team environment.
• Willingness to travel to client sites as needed.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a self-motivated and dedicated CQV Engineer looking for a challenging and rewarding career, we encourage you to apply for this position.

Join our team and be a part of shaping the future of the pharmaceutical industry!