Website Azzur Group
Azzur Group
Company : Azzur Group
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 highly experienced Senior CQV (Commissioning, Qualification, and Validation) Engineer to join our team. The ideal candidate will possess a robust background in CQV activities for facilities, utilities, and equipment within regulated industries such as pharmaceuticals, biotechnology, or life sciences. With 7-12 years of hands-on experience, this role requires expertise in project execution, protocol development, regulatory compliance, and cross-functional collaboration to ensure all systems meet current Good Manufacturing Practices (cGMP) standards.
Key Responsibilities:
Facilities Qualification:
Conduct and oversee Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of cleanrooms, HVAC systems, and controlled environments.
Develop and execute protocols for facility validation including temperature mapping and environmental monitoring.
Support cleanroom design reviews and commissioning activities.
Utilities Qualification:
Perform and manage qualification activities for critical utility systems such as purified water, compressed air, nitrogen, and process gases.
Review and redline utility P&IDs, execute system walkdowns, and ensure system readiness for validation.
Author and review utility-related documents, including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and risk assessments.
Equipment Qualification:
Oversee the qualification of process and laboratory equipment such as autoclaves, freezers, cryogenic units, filling stations, biosafety cabinets, and analytical instruments.
Conduct lifecycle documentation including URS, IOQ, PQ, and validation summary reports.
Develop traceability matrices to ensure compliance with cGMP and regulatory standards.
Project Management & Cross-Functional Collaboration:
Act as the technical lead for CQV projects, providing expertise to cross-functional teams including engineering, quality, and manufacturing.
Coordinate with contractors and vendors to ensure timely execution of commissioning and qualification activities.
Manage validation discrepancies and provide solutions to ensure project timelines are met.
Regulatory Compliance and Documentation:
Ensure compliance with regulatory standards such as FDA, EU GMP, ICH guidelines, and other applicable regulations.
Author comprehensive validation plans, reports, and standard operating procedures (SOPs).
Lead audits and inspections related to CQV activities and provide timely responses to findings.
Requirements
Qualifications and Experience:
Bachelor’s degree in Engineering, Biotechnology, or a related technical field.
7-12 years of progressive experience in CQV activities within the pharmaceutical, biotech, or life sciences industry.
Strong understanding of cGMP, FDA, and international regulatory requirements.
Proven expertise in facility qualification, utility systems, and equipment validation.
Proficient in project management tools and software (e.g., SmartSheet, Blue Mountain, or equivalent).
Excellent problem-solving, organizational, and communication skills.
Preferred Skills:
Experience with automation and computerized systems validation.
Familiarity with industry-standard validation tools such as Kaye validators, thermocouples, and data loggers.
Certification in Lean Six Sigma or related methodologies is a plus.
Benefits
Health Care Plan (Medical, Dental & Vision)
Retirement Plan (401k, IRA)
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.