CQV Engineer Consultant- All Levels!

CQV Engineer Consultant- All Levels!

Location: Raleigh, NC

Department: Azzur Consulting LLC

Job Description

Essential Duties and Responsibilities

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. As a CQV Engineer at Azzur Group, you will play a crucial role in ensuring the successful commissioning, qualification, and validation of processes, systems, and equipment for our clients in the Life Sciences sector. We are seeking candidates at various experience levels to support our growing pipeline of projects. Whether you are a seasoned professional or just starting your career in CQV, we welcome diversity in experience and expertise. The following is a short list of the typical responsibilities and deliverables of any given project.

• Develop and execute commissioning, qualification, and/or validation protocols for equipment, utilities, and/or facilities in accordance with industry regulations and client specifications.

• Contribute to the development and revision of Standard Operating Procedures (SOPs) related to CQV processes and ensure that SOPs are in compliance with regulatory requirements and industry best practices.

• Work collaboratively with project teams to integrate CQV activities seamlessly into project timelines.

• Provide regular updates through technical presentations on the status of validation activities to project teams and stakeholders.

• Uphold high standards of quality in project execution, ensuring compliance with GMP (Good Manufacturing Practices) and regulatory guidelines.

• Identify and assess risks associated with CQV activities and develop mitigation strategies.

Qualifications

• BS in Engineering, Science or equivalent technical degree.

• Solid understanding of GMP regulations and industry standards.

• Excellent communication and interpersonal skills.

• Ability to work independently and collaboratively in a dynamic team environment.

• Experience in commissioning, qualification, and validation within the pharmaceutical and/or medical device industry commensurate with the level of the project demand.

• Strong analytical and problem-solving skills with attention to detail.

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