Director of Validation

  • Location

    United States
  • Salary

  • Job Type

  • Functions

    Quality Assurance

The Company –

Scienta are proud to announce that we are teaming up with New Jerseys leading CDMO! Due to a new location being built, they are now on the search for a Director of Validation to join and establish the team.

The role –

This position reports directly to the V.P. of Quality and is ideally suited for a professional with strong background in facility/utility/equipment/CSV validation. This is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects – that transform the lives of patients.

· Responsible for validation programs in support of CGMP manufacturing of clinical trial materials and commercial products

· Responsible for facility, utility, and equipment qualification programs

· Responsible for QA role of assay validation

· Responsible for computer system validation (CSV)

· Responsible for process and cleaning validation

· Maintain and update facility wide validation master plan, and individual master plans for various systems.

· Supervisor, mentor validation staff with the goal of building a sustaining validation team

Your Profile –

  • BS/MS in life science or related field
  • Experience in drug/biologics industry in GMP production environment in roles of validation/engineering
  • 10+ years’ experience in facility, utility, equipment, instrument validation
  • Working experience in CQV for biotechnology/pharmaceutical facility is required.
  • Familiar with CSV in accordance with, GAMP 5 and CFR Part 11
  • Familiarity with process, cleaning, assay validation a plus
  • Experience in authorship of validation protocols for utility and equipment required.
  • Familiar with GMP operational principles and practices

If this seems like the perfect role for you – click ‘apply now’ or, email a copy of your CV for a private and confidential conversation.

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