At a Glance
- Tasks: Lead the writing of validation documentation for PCR-based testing solutions.
- Company: Join a pioneering fertility diagnostics company focused on precision and regulatory excellence.
- Benefits: Gain valuable experience in a dynamic environment with potential for future opportunities.
- Other info: Fixed-term contract of 6-9 months with a focus on documentation and regulatory compliance.
- Why this job: Make a real impact in healthcare by ensuring compliance and quality in diagnostic products.
- Qualifications: Background in molecular biology and experience in writing validation protocols required.
The predicted salary is between 40000 - 50000 £ per year.
Fixed term contract. 6-9 months.
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.
We are seeking a Validation Engineer on a fixed-term contract (6–9 months) to lead the writing and formalisation 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
- Validation Protocol Writing
- 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 — accuracy and regulatory alignment are paramount.
- Regulatory Compliance
- 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.
- PCR Workflow Understanding
- Apply working knowledge of PCR-based diagnostic workflows to contextualise and validate experimental data.
- Engage with DDP (Droplet Digital PCR) workflows where relevant to the validation programme.
- Liaise with laboratory scientists to ensure technical accuracy of all written outputs.
- Handover & Knowledge Transfer
- 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 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.
