What are the responsibilities and job description for the CQV Cleaning Consultant position at Azzur Group?
We are seeking an experienced CQV Engineer to support the commissioning, qualification, and validation of GMP systems in a regulated manufacturing environment. The ideal candidate will have hands-on experience with manufacturing processes, aseptic fill/finish operations, compressed air systems, and a thorough understanding of FDA regulatory requirements (cGMP, 21 CFR Part 11).
Key Responsibilities:
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.
Key Responsibilities:
- Develop and execute CQV protocols (URS,SOPs, IQ, OQ, PQ) for equipment, utilities, and systems including:
- Fill lines (aseptic and terminal sterilization)
- Compressed air and gas systems
- CIP systems
- Clean utilities (WFI, PW, Clean Steam)
- Review commissioning activities including FAT/SAT and requalification support
- Collaborate with cross-functional teams (Engineering, QA, Manufacturing, Facilities) to ensure systems are qualified and compliant with internal and external standards
- Perform risk assessments (RA), impact assessments (IA), and revise validation master plans
- Lead and support deviation investigations and implement corrective and preventive actions (CAPAs)
- Support process validation and continued process verification (CPV)
- Ensure compliance with FDA & cGMP guidelines
- Review and approve vendor-supplied documentation and participate in design reviews and system walk-downs
- Participate in audits and inspections as the CQV SME for assigned systems
- Experienced in supporting 483 warning letters
- Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, or related discipline)
- 8-10 years of CQV experience in the pharmaceutical, biotech, or medical device industry
- Strong knowledge of GMP environments, FDA regulations
- Hands-on experience with:
- Aseptic manufacturing and filling lines
- Compressed air systems (ISO 8573-1 standards)
- Cleanroom environments and clean utility systems
- Proficient in validation documentation and electronic quality systems
- Excellent communication, organization, and technical writing skills
- Ability to manage multiple priorities and work both independently and within a team.
- Experience with project-based environments (facility expansions)
- Familiarity with validation lifecycle approaches and computerized system validation (CSV)
- Lean/ Six Sigma certification is a plus
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)
