Department: Azzur Princeton, LLC
We at Azzur Group are looking for an experienced CSV Consultant to join our Azzur Consulting: Princeton 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.
- 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
- 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 with decommissioning labs preferred
Education:Minimum of a Bachelor or equivalent discipline required
Full Time Employment with Azzur can offer you:
• Flexible PTO
• 401(k) match
• Bonus Eligibility
• Medical Benefits
• Paid Holidays
• Company provided laptop
Who we are:
Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, quality and consulting services. At Azzur, we look to hire full- time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments.
Using our 4 Core Values as guidance, we expect all Azzur Employees to:
• Put Others First,
• Have the Courage to Take Action,
• Take Personal Responsibility, and
• Have Fun!
Azzur Group is an equal opportunity employer and promotes diverse culture, ethnicity, gender and age 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.