Department: Azzur Denver, LLC
Essential Duties and Responsibilities:
Author and execute Commissioning/Qualification protocols, including summary reports and performing root cause analysis for protocol deviations
Possesses strong organizational, multitasking, and Technical Writing abilities, with a solid background in GxP manufacturing processes, controls and regulatory requirements
Equipment and CSV Qualification of manufacturing/laboratory equipment for Cell and Gene Therapies or similar field
Conduct risk assessments and provide a commissioning timeline of activities to identify and evaluate and prioritize risks associated with commissioning and qualifying
Ability to work well independently and with minimum supervision and identify problematic deviations upfront
Be able to help lead team in defining project strategies, developing goals, and ensures project scope is defined and controlled and requests outside the scope are identified within area of expertise
Be able to clearly communicate on expertise to internal and external teams when needed
Be proficient in project management software (MS Project, Smartsheets, Primavera)
Some travel may be required
Minimum 5 years previous experience of CSV specific experience across diverse projects in a GLP / GMP environment is required
Experience with commissioning and qualification of utilities (compressed air), growth direct system, equipment and CSV qualification of cell and gene therapy equipment required
Experience and detailed knowledge of 21 CFR Part 11 and Eudralex Annex 11 requirements and their application in clinical and commercial manufacturing and lab operations required
Experience and detailed knowledge with GAMP 5 Risk Based Approach, classification
and best practices for validation of computerized systems required
Experience with decommissioning labs preferred
Minimum of a Bachelor or equivalent discipline required
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!