CQV Engineer Job at Azzur Group, Albany, NY

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  • Azzur Group
  • Albany, NY

Job Description

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)

Job Tags

Holiday work, Full time,

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