Commissioning Qualification Verification Engineer

4 weeks ago

New York, United States Novozen Healthcare LLC Full time

CQV Engineer

Strictly No C2C


Responsibilities

  • Develop and execute Commissioning, Qualification, and Validation (CQV) protocols, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
  • Support the qualification of equipment, utilities, and systems in pharmaceutical manufacturing facilities, including HVAC, purified water, clean steam, and more.
  • Participate in the preparation and execution of validation documentation, including validation plans, risk assessments, test scripts, and summary reports.
  • Work closely with cross-functional teams, including process engineers, quality assurance, and project management, to ensure validation activities align with project timelines.
  • Assist in the execution of FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) for equipment and systems.
  • Troubleshoot and resolve issues that arise during commissioning, qualification, and validation activities.
  • Ensure compliance with Good Manufacturing Practices (GMP), FDA, and other regulatory requirements throughout all CQV processes.
  • Maintain detailed and accurate records of validation activities, ensuring all documentation is complete, reviewed, and approved in accordance with internal quality standards.
  • Collaborate with vendors, contractors, and internal teams to ensure that all systems and equipment are qualified and validated for use in a pharmaceutical production environment.
  • Participate in continuous improvement initiatives to enhance validation processes and ensure long-term equipment performance.

Qualifications:

  • Bachelor’s degree in Mechanical, Chemical, Biomedical Engineering, or a related field.
  • 3 years of experience in CQV roles within the pharmaceutical or biopharmaceutical industry.
  • Knowledge of GMP guidelines, FDA regulations, and industry standards for qualification and validation.
  • Hands-on experience with IQ, OQ, and PQ activities.
  • Strong understanding of pharmaceutical equipment, utilities, and processes, such as sterile manufacturing, HVAC systems, and cleanrooms.
  • Excellent problem-solving and analytical skills, with the ability to troubleshoot equipment and system performance.
  • Strong communication and organizational skills, with the ability to document and report on validation activities effectively.

Preferred Qualifications:

  • Experience with validation of clean utilities (e.g., purified water, clean steam, compressed air).
  • Familiarity with risk-based validation approaches, such as ASTM E2500.
  • Experience with computerized systems validation (CSV) and data integrity.
  • Ability to work in a highly regulated environment with strong attention to detail.

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