Verification and Validation Technician (Engineering)

ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE’s proven patent protected circulating tumor cell (CTC) harvesting technology is known as the Parsortix® system.   ANGLE’s Parsortix® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood.

The Parsortix system enables a liquid biopsy (a simple blood test) to be used to provide the circulating metastatic breast cancer cells to the user in a format suitable for multiple types of downstream analyses.  The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility.  The system is epitope independent and can capture all phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as well as CTC clusters in a viable form (alive).  CTCs harvested from the system enable a complete picture of a cancer to be seen; as being an intact cell they allow DNA, RNA and protein analysis as well as cytological and morphological examination and may provide comparable analysis to a tissue biopsy in metastatic breast cancer. Because CTC analysis is a non-invasive process, unlike tissue biopsy, it can be repeated as often as needed. This is important because cancer develops and changes over time and there is a clear medical need for up-to-date information on the status of a patient’s tumor. In addition, the live CTCs harvested by the Parsortix system can be cultured, which offers the potential for testing tumor response to drugs outside the patient.

Join our Team:

This is an exciting time at ANGLE and our team in Guildford are looking for a Verification and Validation Technician (Engineering).

The job holder will join ANGLE’s Product and Technology Development team and contribute to ANGLE’s NPD process by verifying and validating products (IVD instruments) developed by the R&D and Product Development teams.  The job is laboratory-based working in a multi-disciplinary team.  Goals and routes are agreed weekly with the supervisor, but an ability to work independently is expected.

At ANGLE, we foster a dynamic, entrepreneurial approach to translating leading edge translational research into clinical diagnostics. We offer the potential for significant corporate growth and career development. We promote a culture of collaboration and shared excellence while encouraging an open and honest exchange of ideas.

We are always in search of potential employees who share our vision and want to make a difference today. In your submission, please describe your background and what you can bring to our team along with attaching your resume.

Principal Accountabilities:

  • Hands-on bench work, primarily in the area of verifying and validating and instrumentation of RUO/IVD products in the Parsortix® product range.
  • Generating appropriate verification and validation (V&V) documentation through the undertaking of pre-defined V&V studies and tasks; thereby supporting project transition through stages 4 and 5 of ANGLE’s NPD process.
  • Support the development of verification and validation (V&V) documentation prior to V&V task delivery.
  • Provide additional adhoc scientific and technical support to manufacturing processes, R&D programmes and projects.
  • Responsible for accuracy, quality and regulatory compliance of work undertaken.
  • Independently keep a current knowledge base in relevant areas of scientific and technical progress.
  • Contribute to managing the day to day running of assigned V&V activities within the Quality Management System (ISO13485:2016).
  • Undertake additional ad-hoc tasks as required.

Qualifications, Experience, Knowledge and Attributes:

  • B.Sc. or equivalent in Engineering related to instrumentation, calibration, and monitoring. Alternatively, demonstrable laboratory experience gained in verification and validation for the in vitro diagnostics industry.
  • Understanding of programming computer software.
  • Experience working to strict quality standards such as Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, IVD 98/79 EC, ISO14971, GMP, GLP, QSR. A strong understanding of the importance of accurate record keeping within a strictly controlled quality system is essential.
  • Organisational skills and the ability to follow agreed procedures is essential.
  • Manage and deliver production to agreed timetables and according to defined instructions.
  • Strong team player with excellent communication skills, work ethic and attention to detail.
  • Good report writing skills, with the ability to communicate results to technical and non-technical staff.
  • An eye for detail and commitment to high quality data.
  • A flexible, can-do approach to the requirements of the job.

Due to the nature of the role, our requirement is for this position to be Guildford based, office hours, five days per week. 

As a member of our highly skilled and fast-growing team you will receive opportunities for development and a competitive benefits package.

Please let us know if you require disability-related accommodation during the recruitment process so that we can work with you to meet your needs.

Furthermore, please be advised that if you submit an application to us for this position, your application and personal details will be processed in accordance with our Data Privacy Notice for Job Candidates.

Important notice to Employment Businesses/ Agencies:

ANGLE does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact our ANGLE recruitment team to obtain prior written authorisation before referring any candidates. In the absence of such written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ANGLE. ANGLE shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

 

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