At a Glance
- Tasks: Lead the creation of validation documentation for innovative fertility diagnostics.
- Company: Join a pioneering fertility diagnostics company focused on precision and regulatory excellence.
- Benefits: Gain valuable experience in a dynamic field with potential for future opportunities.
- Other info: Fixed-term contract with a chance to work closely with scientific experts.
- Why this job: Make a real difference in healthcare by ensuring compliance and quality in diagnostics.
- Qualifications: Background in molecular biology and experience in writing validation protocols required.
The predicted salary is between 30000 - 40000 £ per year.
About
We are recruiting for a fertility diagnostics company developing PCR-based testing solutions.
With a focus on precision and regulatory rigour, the business is building the validation infrastructure needed to bring its diagnostics platform to market under UK regulatory frameworks.
Fixed term contract. 6‑9 months.
Position Overview
We are seeking a Validation Engineer on a fixed‑term contract (6–9 months) to lead the writing and formalization of the validation documentation suite.
This is a primarily office‑based, documentation‑focused role.
The scientific lead will run the experiments, and the successful candidate will translate those results into fully compliant validation protocols and reports.
The ideal candidate will have a strong grasp of PCR‑based diagnostic workflows, ideally with experience in DDP, and a track record of producing validation documentation to ISO 15189, ISO 13485, MHRA (IVDD/IVDR), and UKAS standards.
At the end of the contract, deliverables and knowledge will be handed over to the incoming Quality Manager.
- Core Responsibilities
- Author comprehensive validation protocols and reports aligned to ISO 15189, ISO 13485, MHRA (IVDD/IVDR) and UKAS requirements; work directly with the scientific lead to understand experimental design and translate results into formal documentation; produce validation reports that may run to several hundred pages, with accuracy and regulatory alignment paramount.
- Ensure all validation documentation meets applicable MHRA (IVDD/IVDR) regulations, maintain awareness of evolving UK IVD regulatory requirements and apply them to documentation deliverables, support preparation for UKAS accreditation activities as required.
- Apply working knowledge of PCR‑based diagnostic workflows to contextualize and validate experimental data; engage with DDP (Droplet Digital PCR) workflows where relevant; liaise with laboratory scientists to ensure technical accuracy of all written outputs.
- Structure validation documentation for long‑term maintainability and ease of handover; deliver a clean, complete handover package to the incoming Quality Manager at contract end; document processes and decisions to support continuity of the quality function.
- Required Qualifications & Experience
- Background in molecular biology or a closely related life science discipline.
- Hands‑on experience in a diagnostic laboratory environment.
- Proven track record writing validation protocols and reports for IVD products.
- Strong working knowledge of ISO 15189, ISO 13485, MHRA IVDD/IVDR, and UKAS standards.
- Experience with PCR‑based diagnostic workflows; DDP experience is advantageous.
- Excellent written communication skills – this is a primarily a documentation role.
- Ability to work independently and manage workload across a hybrid schedule.
- Available for a fixed‑term engagement of 6–9 months.
- #J-18808-Ljbffr
Validation Engineer for Innovative Fertility Diagnostics Company in Coventry employer: The IVF Guide
Join a pioneering startup in Coventry that is dedicated to transforming women's health through innovative diagnostic technology. As a Senior Laboratory Scientist, you will enjoy a collaborative and ambitious work culture, with significant opportunities for career growth and the chance to make a real clinical impact from day one. This role offers a unique environment where your expertise will directly shape the future of the laboratory as it scales, ensuring high standards of quality and compliance while working alongside a mission-driven team.
StudySmarter Expert Advice🤫
We think this is how you could land Validation Engineer for Innovative Fertility Diagnostics Company in Coventry
✨Join Biotechnology Meetups
Get yourself into the loop by joining local biotech meetups or workshops. These events are perfect for making connections with professionals in the field and can often lead to temporary gigs through word-of-mouth. Plus, you'll get to hear about the latest trends and developments directly from the source.
✨Showcase Your Passion in Science
Consider starting a blog or social media channel to showcase your interest in biotechnology. Share the latest research, your insights, and even your projects. This will not only enhance your visibility in the community but also attract potential employers like The IVF Guide who might be scrolling through for talent.
✨Tap into University Resources
If you’re still in school or recently graduated, don’t forget to use your university’s career services. They often have exclusive connections with companies looking for temporary staff. Reach out to them for internship listings and networking opportunities tailored to the biotech sector.
✨Apply Directly on Our Website
When you spot that perfect temporary role at The IVF Guide, make sure to apply directly through our website. This way, you’ll be in the best position to get noticed quickly and can show your enthusiasm for the role while filling out the application.
We think you need these skills to ace Validation Engineer for Innovative Fertility Diagnostics Company in Coventry
Some tips for your application 🫡
Showcase Relevant Lab Skills:In the biotech world, your lab skills are paramount. Make sure your CV highlights specific techniques and equipment you’ve used, such as PCR, gel electrophoresis, or cell culture. This will give us a clear picture of what you can bring to The IVF Guide as a temporary teammate.
Highlight Your Research Experience:If you’ve worked on any research projects — whether during your studies or in previous positions — make sure to detail these in your application. Include the objective, your role, and what you achieved. This will help us see your potential and fit for the temporary position at The IVF Guide.
Keep It Concise and Relevant:Especially for a temporary role, we want to see a clear and focused application. Tailor your CV and cover letter to emphasise the qualifications and experiences that are most relevant to the biotech field and the specific role at The IVF Guide. This shows us you’re genuinely interested and capable.
Be Clear About Your Availability:Since it’s a temporary role, let us know right away when you’re available to start and how long you can commit. Include this in your cover letter — this kind of transparency saves us all time and helps us find the right fit quickly at The IVF Guide.
How to prepare for a job interview at The IVF Guide
✨Brush Up on Your Biotech Basics
Understanding the fundamental concepts in biotechnology is crucial. Be ready to discuss core topics like genetics, molecular biology, or bioinformatics, especially if you're asked technical questions. We suggest revisiting your coursework or recent projects to refresh your memory.
✨Demonstrate Your Adaptability
Since this is a temporary role, they’re likely looking for someone who can jump in and get up to speed quickly. Share experiences where you’ve adapted to new environments, tools, or teams in a short space of time. It shows you're ready to tackle the challenge head-on!
✨Emphasise Your Lab Experience
If you’ve got hands-on experience in lab settings, now’s the time to showcase it. Talk about specific techniques you’ve mastered, like PCR or chromatography, and any relevant safety protocols you’ve followed. These details help paint you as an effective team member from day one.
✨Be Prepared to Explain Your Passion
Hiring managers want to see your motivation, especially for a temporary position in a fast-paced field like biotechnology. Be ready to discuss what excites you about the industry, your career goals, and how this role at The IVF Guide aligns with them. It’s all about showing that you’re not just looking for a job, but a stepping stone in your biotech journey.
