Verification Engineer (Contract)

Competitive Home working. Occasional visits to partner sites in Cambridge, and office in London (Kings Cross)

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Company Description

Our mission at Ori Biotech is to enable patient access to a new generation of life saving cell and gene therapies.  We have created a platform technology which automates cell and gene therapy manufacturing and has the potential to help make these treatments affordable and widely available to patients at scale.

Revolutionary scientific breakthroughs are currently being made in cell and gene therapy (CGT) to treat all types of disease ranging from cancer to rare genetic diseases. The first products using these technologies have come to market, and currently, there are more than 1500 clinical trials underway to bring even more products to the patients who need them.

The problem is that while these treatments are amazing, they are very expensive and can only be produced in very small volumes. This is where Ori Biotech comes in. Ori Biotech’s founding team is made up of cell and gene therapy/ life sciences veterans and has the backing of some of the top VCs in the US and UK.  Having recently closed its £23M Series A funding round in August 2020, the company is entering a rapid growth phase bringing on new team members to service its growing customer base. This is an excellent time to join our world class team and be an integral part of bringing the Ori platform to market.

Job Description

Ori is looking for a Verification Engineer (contract) who has detailed knowledge of the ISO13485 Design and Development processes and how they interface with Engineering PLM systems. Demonstrated experience in taking products to market in a regulated environment is required.

The primary objective of this role is to establish robust Engineering operating mechanisms for R&D across all areas of Ori’s QMS.

Key Responsibilites

The CVE will have the following responsibilities:

  • Specify and implement systems to control Engineering Data from inception and design through to transfer and control in manufacturing.
  • Author ISO13485 compliant Design and Development Work Instructions to reflect the Engineering systems and processes you specify
  • Ensure robust control of current technical documentation in collaboration with third party collaborators.
  • Act as technical reviewer during design reviews, plan and design test protocols.
  • Opportunity to be involved in many other areas of Design and test of an exciting development project.

You should apply if:

  • You are passionate about Ori’s mission to enable patient access to a new generation of life saving cell and gene therapies.
  • Ideally have experience working in cell and gene therapy industry, although other 13485 development / manufacturing experience also considered.
  • Have worked with/for Contract Manufacturing Organizations (CMO).
  • Have experience working with Solid Works and PDM Enterprise (or similar) Vault.
  • ECR/ECO/NC/CAPA/PRS/URS&TRS are acronyms that all make sense to you!
  • You are excited to build a company from the ground up, and are excited about working in an agile, fast paced, and unstructured environment.

Qualifications

  • Masters/Bachelor’s degree in Engineering, or relevant field
  • Demonstrated Experience of full product development lifecycle from ideation through to manufacturing transfer and support.
  • Positive attitude and a strong commitment to delivering quality work.
  • Excellent project management skills and attention to detail
  • Fluent English speaker

Contact Type: Initial period 3 months, extension likely depending on performance