Transport Validation, Scientist / Engineer

Location
London, United Kingdom
Posted
Sep 12, 2020
Ref
8564C72CAF
Required Education
Bachelors Degree
Position Type
Full time
We are looking for a Transport Validation scientist / engineer to join the Cell and Gene Therapy Technology Department to support commercialization of gene therapy products. This role requires someone with good knowledge of Transport Validation activities, who is keen to establish procedures in-house at Orchard Therapeutics. This will include use of risk-based procedures using appropriate tools to evaluate all aspects of the transportation process with understanding of the requirements for gene therapy products. You will work with cross functional teams, with treatment centres and with CMOs to generate documentation to support transport validation activities. You will support of Regulatory questions and Health Authority Inspections. In addition, support of process validation activities is included within this role, to ensure appropriate studies are executed and documented for product commercialisation.

Key Elements and Responsibilities
  • Establish transport validation procedures and templates to standardize approaches to preparation, execution and reporting of activities related to shipping and transport validation
  • Lead / participate in multi-disciplinary teams to perform transport validation risk assessments and gap analyses of current and new routes
  • Identify transport validation requirements, and work with Supply Chain and Operations to implement sustainable shipping controls, processes and methods in the evolving field of gene therapy products
  • Perform transport validation studies in conjunction with vendors, CMOs and contract labs to ensure that products are shipped with compliant, efficient and cost-effective solutions
  • Write and execute process and transport validation documentation, including project plans, validation master plans, protocols, reports and change controls
  • Assess impact of any changes on validation status


Requirements

Required knowledge
  • Understanding of Transport Validation, with reference to industry standards and guidelines
  • Experience with risk-based approaches, such as Failure Modes and Effects Analysis
  • Experience within the pharmaceutical or biopharma industry, preferably in cell and gene therapy.
  • Experience within a Transport Validation role for cold chain and cryogenic solutions.
  • Experience within other aspects of Process Validation.

Skills & Abilities
  • Demonstrated skills and capability in planning, preparing, executing and reporting of validation activities
  • Attention to detail
  • Working across cross functional teams to direct validation activities and drive results
  • Ability to visualize / present data in order to communicate ideas, concepts and results to technical and non-technical audiences
  • Interest in continuous improvement of processes
  • Organization and time management to deliver results

Education

Degree or equivalent higher education qualifications in a science or engineering discipline.

Extensive experience in a Transport Validation role

Orchard Therapeutics is an Equal Opportunity employer.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify