Validation Engineer

Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. We are currently seeking a Senior Quality Validation Engineer who is passionate about ensuring the highest standards of quality in the pharmaceutical and biotechnology sectors. 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.

Requirements

• 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.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.