CSV Consultant

Location: Denver, CO
Department: Azzur Denver, LLC

Job Description

We at Azzur Group are looking for an experienced CSV Consultant to join our Azzur Consulting: Denver team. CSV Engineers must be able to demonstrate accountability, strong communication skills, and knowledge of project scopes within the biotechnology and pharmaceutical industries, for one or more projects within Azzur Group. 

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

Experience: 

 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

Education:

 Minimum of a Bachelor or equivalent discipline required

About Azzur

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!



Apply Now

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