Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!!

We are seeking a highly skilled CQV Engineer to join our consulting team. The CQV Engineer will play a crucial role in ensuring the successful commissioning, qualification, and validation of facilities, equipment, and processes in the pharmaceutical, biotechnology, and medical device industries. The ideal candidate will possess strong technical expertise, project management skills, and a thorough understanding of regulatory requirements.

Key Responsibilities:

Commissioning, Qualification, and Validation: Develop and execute commissioning and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Coordinate and oversee the installation, testing, and validation of equipment and systems. Ensure compliance with regulatory guidelines (FDA, EMA, etc.) and industry standards (GMP, GxP). Prepare and review validation documentation, including Validation Master Plans (VMP), User Requirement Specifications (URS), and risk assessments. Perform validation activities for processes, systems, and equipment, including writing and executing test plans and reports. Identify and resolve deviations and non-conformities, ensuring timely corrective actions. Communicate effectively with clients, project teams, and stakeholders to ensure project objectives are met. Provide technical guidance and mentorship to junior team members. Contribute to the development and implementation of best practices and standard operating procedures (SOPs) in CQV activities. Stay current with industry trends, technological advancements, and regulatory changes.