Website Azzur Group
Azzur Group
Company : Azzur Group
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
Health Care Plan (Medical, Dental & Vision)
Retirement Plan (401k, IRA)
Life Insurance (Basic, Voluntary & AD&D)
Paid Time Off (Vacation, Sick & Public Holidays)