CSV Project Manager

Location: Raritan, NJ
Department: Azzur Princeton, LLC

Job Description

We at Azzur Group are looking for an experienced CSV Project Manager to join our Azzur Consulting: Princeton team.

Project Manager 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, leading project teams through client relationship building, team mentorship, identification of scope and prioritization and the implementation of processes.

Essential Duties and Responsibilities:
  • Understand and manage deliverables of all project requirements originating from the proposal, specifications, meetings, verbal direction, or other means
  • Equipment and CSV Qualification of manufacturing/laboratory equipment for Cell and Gene Therapies
  • Perform (hands on) field execution of commissioning and/or validation documentation
  • 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
  • Conduct risk assessments and provide a commissioning timeline of activities to identify and evaluate and prioritize risks associated with commissioning and qualifying
  • Provide ongoing communication to clients and build client relationships through this process
  • Accountable for core team performance, project schedule and execution, and budget commitments
  • Leads team in defining project strategies, developing goals, and ensures project scope is defined and controlled and requests outside the scope are identified
  • Ensures identification and communication of project risks, development of risk plan and leads core team in the proactive management of risk response strategies.
  • Continuously interacts with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders
  • Actively participate in the mentoring, training of junior engineers and development
  • Be proficient in project management software (MS Project, Smartsheets, Primavera)
  • Some travel may be required
Experience:
  • Minimum 10 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
  • PMP certification is desired
  • PMI or IPMA or equivalent certification desired
Benefits:

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.


Apply Now

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