Validation Engineer

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 CQV Engineer to support and lead qualification efforts for facilities, utilities, and equipment in a regulated manufacturing environment. The successful candidate will focus on ensuring systems are commissioned, qualified, and validated in compliance with cGMP standards and regulatory requirements.

Responsibilities:

• Lead qualification activities for cleanrooms, HVAC systems, and utilities such as purified water, compressed air, and gas systems.
• Conduct system walk-downs, verify P&IDs, and address deficiencies or deviations identified during qualification.
• Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for manufacturing and laboratory equipment, including autoclaves, cryogenic freezers, and biosafety cabinets.
• Oversee validation testing to ensure compliance with regulatory standards and operational requirements.
• Prepare comprehensive qualification protocols, validation summary reports, and traceability matrices in adherence to Good Documentation Practices (GDP).
• Maintain organized and timely records to meet both internal and external audit requirements.
• Execute system testing using tools such as thermocouples, pressure sensors, and data loggers.
• Identify and resolve issues during commissioning and qualification phases.
• Work closely with project teams, including Quality Assurance, Operations, and Engineering, to ensure alignment on validation objectives.
• Support cross-functional teams during audits and regulatory inspections as a subject matter expert (SME) for CQV processes.

Requirements

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 3–8 years of experience in Commissioning, Qualification, and Validation (CQV) in a cGMP-regulated environment.
• Hands-on experience with facilities, utilities, and equipment qualification.
• Proficient in drafting and executing IQ/OQ/PQ protocols.
• Knowledge of regulatory guidelines such as FDA, EU GMP, and ICH.
• Familiarity with validation tools like thermocouples and data loggers.
• Strong communication and problem-solving skills.

Benefits

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.

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