The IVF Guide
Validation Engineer for Innovative Fertility Diagnostics Company
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Fixed term contract. 6-9 months.
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.
Position Overview
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.
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Core Responsibilities
1. 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
2. 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
3. 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
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4. 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
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