Director of Validation

  • Location

    United States
  • Salary

    Negotiable
  • Job Type

    Permanent
  • Functions

    Quality Assurance

Director of Validation

Work Location: New Jersey

Employment Status: Full time, on site

Reports to: VP of Quality

About the company

Part of a large international group, that are a growing company who provide end-to-end CDMO services, from drug discovery to commercialisation, in cell & gene therapy (CGT), vaccines, biologics discovery and more, to accelerate drug development for customers.

Their total cell and gene therapy solution covers CMC of plasmid and virus for IND filing, as well as clinical and commercial manufacturing. They have the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines, and has supported several mRNA vaccine global enterprises to obtain clinical approvals. They also have a stable and high-yield viral vector platform.

About the Position

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.

Responsibilities

  • 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

Qualifications/Experinece

  • 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

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