Cleaning Validation Engineer

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!

This position requires expertise in cleaning validation and monitoring in a cGMP facility. Key requirements include:

• Hands-on experience with CIP/SIP systems, washers, vessels, tanks, and manual cleaning.
• Development and execution of cleaning validation protocols and reports.
• Troubleshooting and optimizing CIP/COP systems, with experience in cycle development preferred.
• Data analysis and presentation of results, ensuring adherence to project specifications and timelines.
• Generation and resolution of protocol discrepancies.
• Review of GxP deliverables (specifications, procedures, validation documents).
• Training of operations staff on relevant protocols and procedures.
• Organization and tracking of validation activities to meet client timelines.
• Experience with various sampling techniques.
• Strong knowledge of cGMP requirements and excellent communication skills.
• Preferred skills: experimental design, problem-solving, organizational abilities, project management, discrepancy reporting, and root cause analysis experience.

Requirements

● Requirements:

• Engineering Degree
• Knowledge of FDA and cGMP regulations
• Able to review and interpret data for scientific conclusions
• Strong written, verbal, and technical writing skills
• Proficient in Microsoft Office; quick to learn new applications
• Hands-on experience with validation in a cGMP environment
• Excellent problem-solving and decision-making abilities
• Capable of extracting information from technical documents
• Proactive in project management and contingency planning
• Skilled in workload management and prioritization
• Able to work independently and multitask to meet deadlines
• Team player with the ability to collaborate effectively

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• 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.