Our goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis.
The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments.
With a thriving culture of ambition and strong innovation goals, Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries.
We're looking for a diligent individual to join our team as a Bioinformatics Software Test Engineer, specialising in biopharma and clinical analysis workflows. This is an entry-level role, and training will be provided.
The role involves testing EPI2ME software products, developed by the EPI2ME software developers, to ensure that workflows are running as expected, that new features have been implemented correctly, and to identify any potential software-critical bugs before release. Key EPI2ME workflows adhere to SaMD regulatory standards (IEC 62304, ISO 13485 and ISO 14971). Software testing should be documented appropriately ensuring audit-readiness and compliance.
The Details.
In this role, you will perform extensive testing, both manual and automated testing pipelines, on EPI2ME workflow products. All testing and verification activities will need to be documented appropriately to ensure audit-readiness and compliance. The role requires this individual to ensure that all workflow software products adhere to regulatory standards for software as a medical device (SaMD; IEC 62304, ISO 13485 ISO 14971). This includes supporting writing, maintaining and supporting verification testing activities, including writing software testing plans and execution of testing plans. The role requires the individual to be able to derive meaningful insights from biological data, and to have a requisite knowledge base encompassing key targets in the biopharma sector and in clinical spheres, as appropriate. The individual is encouraged to work closely with workflow developers in the team. They will continually test and validate EPI2ME workflows using powerful tools to build validation and verification reports. They will ensure the use of an appropriate structured framework to document the outcomes of the evaluation process, which will then be used by developers to improve and refine workflow software. The individual will also support cross-functional risk-management activities across the SaMD lifecycle.
Duties
- Main project focus: BioPharma and Clinical software workflows
- Support all testing and verification activities of EPI2ME workflows, including writing and executing software testing plans, based on software requirements.
- Ensuring all testing activities are recorded appropriately
- Ensure all SaMD products adhere to regulatory guidelines for medical devices, including ISO 13485, ISO 14971 and IEC 62304.
- Collaborate effectively with Customer Workflows, Applied Development and Quality Assurance teams to support compliant workflow development and audit readiness
- Supporting teams to write verification documentation for project Design History Files (DHFs)
- Ensure traceability matrices are maintained between software requirements, software units and items and software testing, and software architecture.
- Utilise a variety of regulatory compliance software including MasterControl, JAMA, Jira, Monday.com.
- Carry out validation and verification and generate metrics to monitor the performance of EPI2ME workflows and associated tools, including sensitivity and specificity calculations
- Maintain knowledge of external advances in the field of long-read data analysis
Maintain knowledge of relevant bioinformatics tools and software
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What We're Looking For.
Essential
- MSc (or equivalent experience), in Bioinformatics, Computer Science, or a closely related discipline, or in a biology-related subject with substantial experience of Bioinformatics and/or data analysis
- Good communication and interpersonal skills for discussing and presenting ideas within the team and with other colleagues
Willingness to adapt, listen and learn new skills.
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Desirable
- Practical experience working with SaMD products
- Practical knowledge of ISO accreditation, regulatory compliance of Medical Device Software (IEC-62304, ISO-13485), GAMP5 guidelines and SaMD.
- Experience writing documentation adhering to ISO/ IEC / GAMP5 guidelines.
- Experience demonstrating independent working in a time-critical environment
- Practical experience with the processing and analysis of large genomic datasets, and their associated metadata
- Practical experience handling sequencing data with exposure to the commonly used software tools (samtools, bcftools) algorithms (alignment, assembly) and file formats (FASTQ, BAM, VCF)
- Familiarity with long-read sequencing data analysis
- Expertise in Biopharma / clinical bioinformatics workflows
- Strong analytical skills with the ability to collect, organise, analyse, and disseminate significant amounts of information with attention to detail and accuracy
- Knowledge of general programming concepts with the ability to comprehend popular programming languages
- Knowledge of the nuances of the application of bioinformatics workflows in a clinical diagnostic environment
- Ability to learn independently to use new software tools and systems
Versatility and the ability to work on multiple project facets simultaneously
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We offer outstanding benefits to include an attractive bonus, generous pension contributions, private healthcare and an excellent starting salary. Based within beautiful, landscaped surroundings with tree-lined walks, water features and a lake, all of which make for a wonderful working environment.
Looking to utilise your skills to really make a difference to humankind? Then consider joining our team and apply today!
Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job.
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